NCT04803201|SuspendedPhase 2DMCFDA Drug

Study Stopped

Interim Analysis

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

A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

A051902NCI-2021-01380U10CA180821

Study Type

interventional

Target

170

Locations

1 country

Sites

Timeline

RegisteredMar 2021

StartedOct 2021

CompletionMay 2027

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended

Enrollment

170

participants targeted

Target at P75+ for phase_2

Timeline

12mo left

Started Oct 2021

Longer than P75 for phase_2

Geographic Reach

1 country

86 active sites

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.6 years study duration

Study Progress82%

Oct 2021May 2027

First Submitted

Initial submission to the registry

March 15, 2021

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed

7 months until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

5.6 years

First QC Date

March 15, 2021

Last Update Submit

May 5, 2026

Conditions

Angioimmunoblastic T-cell Lymphoma Follicular T-Cell Lymphoma Enteropathy-Associated 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

Outcome Measures

Primary Outcomes (1)

Complete remission (CR) rate
Defined as the number of patients with complete remission (CR) divided by the total number of patients randomized. Will be measured by fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) at the completion of treatment (at end of treatment) and will be compared between each experimental arm and control arm. Final analyses will use z-scores obtained from a stratified Cochran-Mantel-Haenszel test to compare the CR rates between each experimental arm and control arm. For each treatment arm, CR rates will be estimated with their 95% confidence intervals.
Up to 6 months

Secondary Outcomes (8)

Incidence of adverse events
Up to 5 years
Overall response rate (ORR)
Up to 6 months
Duration of response
From first date of complete or partial remission until the earlier of disease progression, death from any cause, or non-protocol lymphoma-directed therapy to treat residual or progressive disease, assessed up to 5 years
Progression-free Survival (PFS)
From randomization date until the earlier of disease progression, death from any cause, or non-protocol lymphoma-directed therapy to treat residual or progressive disease, assessed up to 5 years
Event-free Survival (EFS)
From randomization date until earlier of non-protocol lymphoma-directed therapy for any reason (excluding planned consolidative transplant), disease progression, or death from any cause, assessed up to 5 years
+3 more secondary outcomes

Study Arms (3)

Arm A (duvelisib, CHO[E]P)

EXPERIMENTAL

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.

Drug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: EtoposideDrug: Duvelisib

Arm B (CC-486, CHO[E]P)

EXPERIMENTAL

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.

Drug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: EtoposideDrug: Oral azacitidine

Arm C (CHO[E]P)

ACTIVE COMPARATOR

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.

Drug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: Etoposide