Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

Conditions

• Angioimmunoblastic T-cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma
• Follicular T-Cell Lymphoma
• Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
• Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
• Peripheral T-Cell Lymphoma, Not Otherwise Specified

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin — DRUG
  Given IV
• Vincristine — DRUG
  Given IV
• Prednisone — DRUG
  Given PO
• Etoposide — DRUG
  Given IV or PO
• Duvelisib — DRUG
  Given PO
• Oral azacitidine — DRUG
  Given PO

Study Details

This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma.

Key Dates

First listed

Mar 17, 2021

Start date

Oct 8, 2021

Status verified

Aug 2026

Primary completion

May 19, 2027

Completion

May 19, 2027

Study Design

Enrollment

170 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (duvelisib, CHO[E]P)
  Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =\< 60 years old, and prednisone PO QD on days 1-5. Patients also receive duvelisib PO BID on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (CC-486, CHO[E]P)
  Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =\< 60 years old, and prednisone PO QD on days 1-5. Patients also receive CC-486 PO QD on days -6 to 0 of cycle -1 and days 8-21 of cycles 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm C (CHO[E]P)
  Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =\< 60 years old, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete remission (CR) rate [ Time Frame: Up to 6 months ]

Central Contacts

• Neha Mehta-Shah, MD, MSCI
  314-747-7510
  [email protected]

Locations (96)

Find similar trials in Little Rock, AR

Related Studies

• Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
  Recruiting · Emory University · Atlanta, Georgia
• Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
  PHASE1 · Recruiting · SciTech Development, Inc. · Scottsdale, Arizona
• A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
  PHASE1/PHASE2 · Recruiting · Dren Bio · Birmingham, Alabama
• A Registry for People With T-cell Lymphoma
  Recruiting · Memorial Sloan Kettering Cancer Center · Duarte, California