Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy

May 13, 2026 updated by: Eastern Cooperative Oncology Group

A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients With Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)

This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm.

SECONDARY OBJECTIVES:

I. To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm.

II. To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy).

III. To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem cell transplant (ASCT) arm.

EXPLORATORY OBJECTIVE:

I. To determine the impact of minimal residual disease (MRD) on the benefit of autologous stem cell transplant (ASCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.

ARM II: Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years for a total of 12 years from the date of randomization.

Study Type

Interventional

Enrollment (Estimated)

294

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama at Birmingham Cancer Center
        • Contact:
        • Principal Investigator:
          • Lauren K. Shea
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Fairbanks, Alaska, United States, 99701
        • Active, not recruiting
        • Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital in Arizona
        • Principal Investigator:
          • Nabila N. Bennani
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Principal Investigator:
          • Muhammad Husnain
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Principal Investigator:
          • Muhammad Husnain
        • Contact:
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Christina Poh
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Nicole Foley
      • Martinez, California, United States, 94553-3156
        • Active, not recruiting
        • Contra Costa Regional Medical Center
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Nicole Foley
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • Providence Santa Rosa Memorial Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Walnut Creek, California, United States, 94598
        • Active, not recruiting
        • BASS Medical Group - Lennon
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, United States, 80303
        • Active, not recruiting
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, United States, 80304
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, United States, 80112
        • Active, not recruiting
        • Rocky Mountain Cancer Centers - Centennial
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80209
        • Active, not recruiting
        • The Women's Imaging Center
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Rose
      • Englewood, Colorado, United States, 80113
        • Active, not recruiting
        • Rocky Mountain Cancer Centers - Swedish
      • Englewood, Colorado, United States, 80113
        • Active, not recruiting
        • The Melanoma and Skin Cancer Institute
      • Lakewood, Colorado, United States, 80228
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, United States, 80124
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Longmont
      • Thornton, Colorado, United States, 80260
        • Active, not recruiting
        • Rocky Mountain Cancer Centers-Thornton
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Beebe Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Nabila N. Bennani
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center-International Plaza
        • Contact:
        • Principal Investigator:
          • Aleksandr Lazaryan
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Contact:
        • Principal Investigator:
          • Aleksandr Lazaryan
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Aleksandr Lazaryan
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Pamela B. Allen
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contact:
        • Principal Investigator:
          • Utpal P. Dave
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Eric Mou
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
        • Principal Investigator:
          • Hassaan Yasin
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Contact:
        • Principal Investigator:
          • Hassaan Yasin
      • Paducah, Kentucky, United States, 42003
        • Active, not recruiting
        • Mercy Health - Paducah Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Principal Investigator:
          • Ashley D. Staton
        • Contact:
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Sciences Center at Shreveport
        • Contact:
        • Principal Investigator:
          • Shashank Cingam
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Recruiting
        • Christiana Care - Union Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • Dipenkumar Modi
        • Contact:
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Principal Investigator:
          • Dipenkumar Modi
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Nabila N. Bennani
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center - Briarcliff
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
          • Site Public Contact
          • Phone Number: 913-588-3671
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
    • Montana
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Danielle Wallace
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Anne W. Beaven
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Bei Hu
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Clemmons, North Carolina, United States, 27012
        • Recruiting
        • Wake Forest University at Clemmons
        • Principal Investigator:
          • Rakhee Vaidya
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9259
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Jie Wang
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Novant Health Cancer Institute - Huntersville
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Novant Health Presbyterian Medical Center Huntersville
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Kernersville, North Carolina, United States, 27284
        • Recruiting
        • Novant Health Cancer Institute - Kernersville
        • Contact:
        • Principal Investigator:
          • James P. Dugan
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Novant Health Cancer Institute - Matthews
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Matthews Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Mooresville, North Carolina, United States, 28117
        • Recruiting
        • Novant Health Cancer Institute - Mooresville
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Mount Airy, North Carolina, United States, 27030
        • Recruiting
        • Novant Health Cancer Institute - Mount Airy
        • Contact:
        • Principal Investigator:
          • James P. Dugan
      • North Wilkesboro, North Carolina, United States, 28659
        • Recruiting
        • Novant Health Cancer Institute - Wilkesboro
        • Contact:
        • Principal Investigator:
          • James P. Dugan
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Rowan Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Alan P. Skarbnik
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Novant Health Cancer Institute - Statesville
        • Contact:
        • Principal Investigator:
          • James P. Dugan
      • Thomasville, North Carolina, United States, 27360
        • Recruiting
        • Novant Health Cancer Institute - Thomasville
        • Contact:
        • Principal Investigator:
          • James P. Dugan
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Rakhee Vaidya
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Contact:
        • Principal Investigator:
          • James P. Dugan
    • Ohio
      • Athens, Ohio, United States, 45701
        • Recruiting
        • OhioHealth O'Bleness Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Columbus Oncology and Hematology Associates Inc
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Grant Medical Center
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Columbus, Ohio, United States, 43228
        • Recruiting
        • Doctors Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Delaware Health Center-Grady Cancer Center
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Grady Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Columbus Oncology and Hematology Associates
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Dublin Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Mansfield, Ohio, United States, 44903
        • Recruiting
        • OhioHealth Mansfield Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Marion, Ohio, United States, 43302
        • Recruiting
        • OhioHealth Marion General Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Pickerington, Ohio, United States, 43147
        • Recruiting
        • OhioHealth Pickerington Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Basem M. William
      • Westerville, Ohio, United States, 43082
        • Recruiting
        • OhioHealth Westerville Medical Campus/Westerville Cancer Center
        • Contact:
        • Principal Investigator:
          • Basem M. William
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Taha Al-Juhaishi
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Hood River, Oregon, United States, 97031
        • Recruiting
        • Providence Hood River Memorial Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Amrita Desai
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Principal Investigator:
          • Joseph P. Lynch
        • Contact:
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Principal Investigator:
          • Joseph P. Lynch
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Ashwath Gurumurthi
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Lauren Lee
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Sneha Purvey
        • Contact:
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Mount Vernon, Washington, United States, 98274
      • Port Townsend, Washington, United States, 98368
        • Active, not recruiting
        • Jefferson Healthcare
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Cancer Care Northwest - Spokane South
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99216
        • Recruiting
        • Cancer Care Northwest-Valley
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Cancer Care Northwest-North Spokane
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Principal Investigator:
          • Priyanka Pophali
        • Contact:
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Principal Investigator:
          • Priyanka Pophali
        • Contact:
      • Marshfield, Wisconsin, United States, 54449
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
        • Principal Investigator:
          • Kaitlin Annunzio
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Kaitlin Annunzio
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • New Berlin, Wisconsin, United States, 53151
        • Recruiting
        • Froedtert and MCW Moorland Reserve Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Kaitlin Annunzio
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Kaitlin Annunzio
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7632
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Kaitlin Annunzio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must be 18 to 75 years of age
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories:

    • Anaplastic large cell lymphoma (ALCL) ALK-negative
    • Angioimmunoblastic T-cell lymphoma (AITL)
    • Nodal PTCL with follicular helper T cell (TFH) phenotype
    • Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)

  • Patient must have undergone induction treatment with an anthracycline based chemotherapy.

    • NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission

  • Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT

    • NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review
    • NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR)
  • Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm
  • Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines
  • Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization)
  • Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Other: Best Practice
Receive standard of care observation
Other Names:
  • standard of care
  • standard therapy
Procedure: Computed Tomography
Undergo CT or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
Procedure: Bone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
Other Names:
  • Biopsy of Bone Marrow
  • Biopsy, Bone Marrow
Experimental: Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Leukapheresis
Undergo leukapheresis
Other Names:
  • Leukocytopheresis
  • Therapeutic Leukopheresis
  • Leukocyte Adsorptive Apheresis
  • White Blood Cell Reduction Apheresis
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo ASCT
Other Names:
  • Autologous Stem Cell Transplantation
  • AHSCT
  • Autologous
  • Autologous Hematopoietic Cell Transplantation
  • Autologous Stem Cell Transplant
  • Stem Cell Transplantation, Autologous
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
Procedure: Bone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
Other Names:
  • Biopsy of Bone Marrow
  • Biopsy, Bone Marrow
Drug: High Dose Chemotherapy
Receive high dose chemotherapy
Other Names:
  • high-dose chemotherapy
Drug: Stem Cell Mobilization Therapy
Receive stem cell mobilization therapy
Other Names:
  • Stem-cell mobilization
  • Chemomobilization
  • Hematopoietic Stem Cell Mobilization
  • Mobilization Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years
Stratified logrank test will be used for the primary analysis of the comparison of PFS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.
From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From study randomization to death due to any cause, assessed up to 12 years
Stratified logrank test will be used for the primary analysis of the comparison of OS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.
From study randomization to death due to any cause, assessed up to 12 years
Cumulative incidence of relapse
Time Frame: Up to 12 years
The cumulative incidence of relapse will be analyzed under the competing risk framework using competing risk regression and competing risk cumulative incidence function plots.
Up to 12 years
Cumulative incidence of mortality
Time Frame: Up to 12 years
The cumulative incidence of mortality will be analyzed under the competing risk framework using competing risk regression and competing risk cumulative incidence function plots.
Up to 12 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with minimal residual disease (MRD) negative result after autologous stem cell transplant (ASCT) in arm B
Time Frame: Up to 12 years
The proportion of patients with MRD negative results after ASCT will be reported among arm B patients. MRD negative is defined as no lymphoma cell detected.
Up to 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Nabila N Bennani, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4232 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2024-06604 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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