- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04331119
Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
July 30, 2023 updated by: Washington University School of Medicine
Phase II Trial With Safety Lead in of Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
The investigators hypothesize that duvelisib maintenance after autologous stem cell transplant in patients with T-cell lymphomas will be safe and well tolerated, and will improve progression free survival.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Phase 2
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
- Name: Amanda Cashen, M.D.
- Phone Number: 314-454-8323
- Email: acashen@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Sub-Investigator:
- Raya Saba, M.D., M.S.C.I.
-
Sub-Investigator:
- Geoffrey Uy, M.D.
-
Sub-Investigator:
- John F DiPersio, M.D., Ph.D.
-
Sub-Investigator:
- Ningying Wu, M.D., Ph.D.
-
Sub-Investigator:
- Peter Westervelt, M.D., Ph.D.
-
Sub-Investigator:
- Camille Abboud, M.D.
-
Sub-Investigator:
- Keith Stockerl-Goldstein, M.D.
-
Sub-Investigator:
- Ravi Vij, M.D.
-
Sub-Investigator:
- Todd Fehniger, M.D., Ph.D.
-
Sub-Investigator:
- Meagan Jacoby, M.D., Ph.D.
-
Sub-Investigator:
- Iskra Pusic, M.D.
-
Sub-Investigator:
- Lukas Wartman, M.D.
-
Sub-Investigator:
- John Welch, M.D., Ph.D.
-
Contact:
- Amanda Cashen, M.D.
- Phone Number: 314-454-8323
- Email: acashen@wustl.edu
-
Principal Investigator:
- Amanda Cashen, M.D.
-
Sub-Investigator:
- Mark Schroeder, M.D.
-
Sub-Investigator:
- Matthew Walter, M.D.
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of T cell non-Hodgkin lymphoma, T cell lymphomas included are peripheral T cell lymphoma not otherwise specified, angioimmunoblastic T cell lymphoma, and systemic anaplastic large cell lymphoma.
- Eligible for autologous stem cell transplantation as determined by the treating physician or completed autologous transplant within the last 30 days.
- At least 18 years of age at time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate organ function as defined below:
- Serum creatinine ≤ 1.5 times institutional upper limit of normal (IULN)
- Total bilirubin ≤ 1.5 x IULN. Patients with Gilbert's Syndrome may have a bilirubin > 1.5 x IULN
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1.0 x 109/L
- Platelet count ≥ 75 x 109/L
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Women of childbearing potential and men must agree to use highly effective contraception prior to study entry and for the duration of study participation and for 3 months after the last dose of duvelisib. Negative serum β human chorionic gonadotropin (βHCG) pregnancy test within 7 days before first treatment is required if the patient is a woman of childbearing potential.
- Participants or a participant's legally authorized representative must be able to understand and willing to sign an IRB approved written informed consent document
Exclusion Criteria:
- Currently receiving any other experimental therapy or has received experimental therapy within 4 weeks prior to study treatment
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to duvelisib or other agents used in the study.
- Prior history of drug-induced colitis or drug-induced pneumonitis
- History of concurrent interstitial lung disease or severely impaired lung function
- History of chronic liver disease or veno-occlusive disease
- History of tuberculosis within 2 years prior to enrollment
- Administration of a live or live attenuated vaccine within 6 weeks of first duvelisib dose
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) per day
- Ongoing treatment for systemic bacterial, fungal, or viral infections at screening.
Note: patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded is all other inclusion/exclusion criteria are met
- Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
- Infection with HBV, HCV. Subjects with a positive HBsAg or HCV Ab on pre-transplant infection screening will be excluded. Subjects with a positive HBcAb must have negative HBV DNA to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines.
- Baseline QTcF > 500 milliseconds. This does not apply to subjects with right or left bundle branch blocks
- Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment.
- Clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea,vomiting, or any other condition that will interfere significantly with drug absorption
- Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
- Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with detectable viral load)
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmia.
- Pregnant or breastfeeding.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) are contraindicated).
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Duvelisib Maintenance
|
SecuraBio will supply duvelisib
Other Names:
-Prior to transplant, cycle 1 day 1 of duvelisib, and at the time of all imaging studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 2 years
|
The PFS time will be calculated as the duration of time from autologous stem cell transplant (day 0) to the date of earliest progression or death, whichever occurs first.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerabilty as measured by number of study treatment related adverse events
Time Frame: From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
|
-Adverse events will be assessed using CTCAE v5.0 criteria
|
From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
|
Safety and tolerabilty as measured by discontinuations due to treatment-related adverse events
Time Frame: From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
|
From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)
|
|
Overall response rate (ORR)
Time Frame: 100 days after transplant
|
-Defined as the percentage of patients with a confirmed complete or partial response, monitored with PET/CT scans.
|
100 days after transplant
|
Overall survival (OS)
Time Frame: 2 years
|
-Defined as the duration of time from the date of first dose of study treatment to death from any cause.
Patients who are alive by the data cutoff date will be censored at the last follow up.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amanda Cashen, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 23, 2020
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
March 30, 2020
First Submitted That Met QC Criteria
March 30, 2020
First Posted (Actual)
April 2, 2020
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 30, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202005165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on T-Cell Lymphoma
-
University of Alabama at BirminghamTerminatedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T-cell Lymphomas | Adult T-cell Leukemia | Adult T-cell Lymphoma | Peripheral T-cell Lymphoma Unspecified | T/Null Cell Systemic Type | Cutaneous t-Cell Lymphoma With Nodal/Visceral DiseaseUnited States
-
National Cancer Institute (NCI)WithdrawnHepatosplenic T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Adult T-cell Leukemia/Lymphoma | Extranodal NK-/T-cell Lymphoma, Nasal Type | Monomorphic Epiteliotrophic Intestinal T-cell LymphomaUnited States
-
BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Taiwan, Germany, France, Canada, Italy
-
National Cancer Institute (NCI)CompletedPeripheral T-Cell Lymphoma (PTCL) | T-Cell Prolymphocytic Leukemia | Cutaneous T Cell Lymphoma (CTCL) | T-Cell Lymphoma Relapsed | Adult T-Cell Leukemia (ATL)United States
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Yonsei University; Korea Cancer...CompletedCutaneous T Cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-negative | Angioimmunoblastic T Cell Lymphoma | Peripheral T Cell Lymphoma UnspecifiedKorea, Republic of
-
SciTech Development, LLCRush University Medical CenterRecruitingMycosis Fungoides | Cutaneous T-cell Lymphoma | Peripheral T-cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Cutaneous/Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Classified | Primary Cutaneous T-cell Lymphoma | Cutaneous T-Cell Lymphoma, Unspecified | Follicular... and other conditionsUnited States
-
Deepa JagadeeshRecruitingAngioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Adult T-cell Leukemia/Lymphoma | Enteropathy Associated T-cell Lymphoma | Hepato-splenic T-cell Lymphoma | NK T-cell LymphomaUnited States
-
Shanghai General Hospital, Shanghai Jiao Tong University...SuspendedAngioimmunoblastic T-cell Lymphoma | Peripheral T Cell Lymphoma | Anaplastic Lymphoma | Acute T Cell Leukemia | T-lymphoblastic LymphomaChina
-
Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States
-
Wuhan Union Hospital, ChinaWuhan Bio-Raid Biotechnology Co, Ltd. ChinaUnknownHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T Cell Lymphoma | NK/T-cell Lymphoma | Adult T-Cell Lymphoma/LeukaemiaChina
Clinical Trials on Duvelisib
-
Ruijin HospitalNot yet recruitingFollicular Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Peripheral T Cell Lymphoma | Richter Syndrome | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
-
Washington University School of MedicineNational Cancer Institute (NCI); The Foundation for Barnes-Jewish Hospital; S...RecruitingAcute Lymphocytic Leukemia | Non-hodgkin LymphomaUnited States
-
SecuraBioCompletedPeripheral T-cell LymphomaUnited States, United Kingdom, Germany, Italy
-
Liling ZhangCSPC Ouyi Pharmaceutical Co., Ltd.RecruitingNewly Diagnosed Peripheral T-cell LymphomaChina
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingT-cell Large Granular Lymphocyte Leukemia | T-cell Lymphomas | T-cell Prolymphocytic Leukemia | NK-Cell LymphomasUnited States
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownFollicular LymphomaChina
-
National Heart, Lung, and Blood Institute (NHLBI)TerminatedChronic Lymphocytic Leukemia (CLL) | Small Lymphocytic Leukemia (SLL)United States
-
Emory UniversityVerastem, Inc.Completed
-
SecuraBioTerminatedHematologic MalignanciesUnited States
-
SecuraBioCompleted