Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Sponsors

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Collaborator: Columbia University
NorthShore University HealthSystem
University of Rochester
Medical College of Wisconsin
University of Nebraska
Sanofi
University Hospitals Seidman Cancer Center

Source Memorial Sloan Kettering Cancer Center
Brief Summary

The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.

Detailed Description

Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Overall Status Recruiting
Start Date 2015-10-01
Completion Date 2023-10-01
Primary Completion Date 2023-10-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
progression-free survival (PFS) at +/- 2 weeks
Secondary Outcome
Measure Time Frame
the impact of CD34+ cell dose on lymphocyte subset recovery day 15
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: leukapheresis

Intervention Type: Drug

Intervention Name: Plerixafor

Description: Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for a maximum of 4 apheresis days, for the achievement of ≥ 7 x106 CD34+ cells/kg.

Intervention Type: Drug

Intervention Name: carmustine, etoposide, cytarabine, melphalan

Description: Carmustine 300 mg/m2 day -6 Etoposide 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Cytarabine 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Melphalan 140 mg/m2 day -1 BEAM dosages may be adjusted per institutional dose adjustments based on body weight.

Other Name: BEAM chemotherapy

Intervention Type: Procedure

Intervention Name: Autologous Stem Cell Transplantation

Eligibility

Criteria:

Inclusion Criteria: - Age ≥ 18 years old - Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy - KPS ≥ 70 - Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy. - Eligible for high-dose therapy and autologous stem-cell rescue - Serum creatinine ≤ 1.5 mg/dL, or if creatinine >1.5 mg/dL, calculated creatinine clearance of ≥50 mL/min by 24 hour creatinine clearance or CKD-EPI. - Last cycle of most recent salvage therapy within 8 weeks of enrollment - Total bilirubin < 2.0 mg/dL o If Gilbert"s disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin must be < 2.0 mg/dL - Females of childbearing potential and males must agree to use an acceptable form of contraception per institutional practices. Exclusion Criteria: - Disease progression by IWG Working Group or ICML Criteria since last therapy - Prior autologous or allogeneic stem cell transplantation - HIV infection - Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue - Treatment plan that includes post-transplant maintenance therapy - Salvage therapy that includes involved field radiotherapy

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Craig Sauter, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Overall Contact

Last Name: Craig Sauter, MD

Phone: 212-639-3460

Location
Facility: Status: Contact: Investigator:
University of Nebraska Medical Center | Omaha, Nebraska, 68198-7680, United States Recruiting Matthew Lunning, D.O. Matthew Lunning, D.O. Principal Investigator
Memoral Sloan Kettering Basking Ridge (Consent and Follow-Up Only) | Basking Ridge, New Jersey, United States Recruiting Craig Sauter, MD 212-639-3460
Memorial Sloan Kettering Monmouth (Consent and Follow up Only) | Middletown, New Jersey, 07748, United States Recruiting Craig Sauter, MD 212-639-3460
Memorial Sloan Kettering Bergen (Consent and Follow Up Only) | Montvale, New Jersey, 07645, United States Recruiting Craig Sauter, MD 212-639-3460
Memorial Sloan Kettering Commack (Consent and Follow-up Only) | Commack, New York, 11725, United States Recruiting Craig Sauter, MD 212-639-3460
Memorial Sloan Kettering Westchester | Harrison, New York, 10604, United States Recruiting Craig Sauter, MD 212-639-3460
Northwell Health | Manhasset, New York, 11030, United States Recruiting Ruthee-lu Bayer, MD 516-734-8973
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Recruiting Craig Sauter, MD 212-639-3460 Craig Sauter, MD Principal Investigator
Columbia University | New York, New York, United States Recruiting Markus Mapara, MD 212-305-5098
University of Rochester Medical Center | Rochester, New York, 14642, United States Recruiting Michael Becker, MD 585-275-5823 Michael Becker, MD Principal Investigator
Memorial Sloan Kettering Nassau (Consent and Follow up Only) | Uniondale, New York, 11553, United States Recruiting Craig Sauter, MD 212-639-3460
Tennessee Oncology | Nashville, Tennessee, 37203, United States Recruiting Carlos Bachier, MD 615-342-7440
Texas Transplant Institute | San Antonio, Texas, 78229, United States Recruiting Paul Shaughnessy, MD 210-575-3817 Paul Shaughnessy, MD Principal Investigator
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Active, not recruiting
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 3-4 x 10^6 CD34+ stem cells/kg

Type: Active Comparator

Description: Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Label: 6-8 x10^6 CD34+ stem cells/kg

Type: Experimental

Description: Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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