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Alkylating agent

Duvelisib/CC-486 + Chemotherapy for Lymphoma

Phase 2

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effect of combining duvelisib or CC-486 with usual chemotherapy drugs in treating patients with peripheral T-cell lymphoma.

Who is the study for?

Adults (18+) with peripheral T-cell lymphoma, not including certain subtypes or those with large cell transformation of mycosis fungoides. Participants must have less than 10% CD30 expression in tumors and no active viral infections like HIV or hepatitis B/C unless managed properly. No other concurrent cancers requiring treatment within the last 3 years, except for some localized cases. Must not have had prior systemic therapy for lymphoma, be pregnant/nursing, and should have adequate organ function.

What is being tested?

The trial is testing how well duvelisib or CC-486 works alongside usual chemotherapy drugs (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone) in treating peripheral T-cell lymphoma. Duvelisib targets enzymes needed for cancer growth while CC-486 and other chemotherapies aim to kill or stop cancer cells from growing and spreading.

What are the potential side effects?

Potential side effects include problems related to liver function due to enzyme inhibition by duvelisib; typical chemotherapy side effects such as nausea, hair loss, fatigue; increased risk of infection; blood-related issues like anemia; possible heart complications; allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.

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I can take care of myself and am up and about more than half of my waking hours.

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I haven't had any treatment for lymphoma, except for corticosteroids.

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I can safely receive all drugs in the chemotherapy plan without severe side effects.

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I have tissue samples from previous procedures that can be submitted.

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I do not have HTLV 1/2.

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My lymphoma is a specific type with low CD30 expression.

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I haven't had serious heart problems in the last 6 months.

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My cancer has not spread to my brain or spinal cord.

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I am 18 years old or older.

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My tumor does not show high levels of CD30.

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My cancer type is not excluded by the trial's criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete remission (CR) rate

Secondary study objectives

Correlation of follicular helper T-cell phenotype with response, PFS, EFS and OS

Duration of response

Event-free Survival (EFS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (CC-486, CHO[E]P)Experimental Treatment6 Interventions

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.

Group II: Arm A (duvelisib, CHO[E]P)Experimental Treatment6 Interventions

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.

Group III: Arm C (CHO[E]P)Active Control5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Duvelisib

2016

Completed Phase 3

~760

Etoposide

2010

Completed Phase 3

~2960