Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas

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Brief Title

Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas

Official Title

Phase II Trial With Safety Lead in of Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas

Brief Summary

      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 Phase

Phase 2

Study Type


Primary Outcome

Progression-free survival (PFS)

Secondary Outcome

 Safety and tolerabilty as measured by number of study treatment related adverse events


T-Cell Lymphoma



Study Arms / Comparison Groups

 Duvelisib Maintenance
Description:  Duvelisib maintenance at 25 mg PO BID after count recovery (approximately 30 days after transplant) for one year. If the patient is in a complete remission at day +100, with no evidence of disease on PET/CT, then the dosing schedule of duvelisib may be changed to 25 mg BID for 14 days, then 14 days off in 28 day cycles (at the treating physician's discretion). If the patient has residual disease, duvelisib will continue at 25 mg BID until they have a negative PET CT. PET CTs will be completed every 3 months for patients with residual disease. Duvelisib maintenance will be continued for one year post-transplant.
Starting on 06/10/2021, all new participants will be enrolled to take 25 mg BID of duvelisib on days 1-14 of a 28 day cycle.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 23, 2020

Completion Date

July 31, 2026

Primary Completion Date

July 31, 2026

Eligibility Criteria

        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

          -  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).




18 Years - N/A

Accepts Healthy Volunteers



Amanda Cashen, M.D., 314-454-8323, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Washington University School of Medicine



Study Sponsor

Amanda Cashen, M.D., Principal Investigator, Washington University School of Medicine

Verification Date

July 2022