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

NCT04331119 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 202005165
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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 Outcomes (4)

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

  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

  From start of treatment through 30 days after last dose of duvelisib (estimated to be 13 months)

• Overall response rate (ORR)

  100 days after transplant

• Overall survival (OS)

  2 years

Study Arms (1)

Duvelisib Maintenance

EXPERIMENTAL

* 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.

Drug: Duvelisib; Procedure: Peripheral blood draw

Interventions

Duvelisib DRUG

SecuraBio will supply duvelisib

Also known as: Copiktra

Duvelisib Maintenance

Peripheral blood draw PROCEDURE

-Prior to transplant, cycle 1 day 1 of duvelisib, and at the time of all imaging studies

Duvelisib Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• SecuraBio: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Amanda Cashen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: July 23, 2020
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)