CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

Phase 2

Completed

• Conditions: Previously Untreated Peripheral T-cell Lymphoma
• Interventions: Drug: CC-486 Administration; Drug: CHOP Administration

• Registration Number: NCT03542266
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.

Detailed Description

Study Summary:

This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with Peripheral T-cell Lymphoma (PTCL) who have received no prior systemic therapy. The main objective is to determine the complete response rate (CR) of CC486-CHOP in PTCL. CR rate after cycle 6 will be used for the purpose of interim efficacy analysis.

* The study includes 6 cycles (\~18 weeks) of treatment and 2 years of follow-up. The projected end date is 12/31/2022. Patients achieving complete remission will be evaluated every 6 months for 2 years or until disease progression. Patients who have disease progression will be contacted every 6 months to assess for survival status.

* Standard dose CHOP will be provided on day 1 of each cycle and repeat every 3 weeks for a total of 6 cycles.

* CC486 at 300 mg daily will be administered orally from day -6 to day 0 for cycle 1 priming, and on days 8-21 following cycles 1-5.

* Patients in CR/PR following 6 cycles of treatment have the option to proceed to consolidative autologous stem cell transplant.

* Will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Study Start: 2018-06-01
• Primary Completion: 2020-03-25
• Results First Submitted: 2021-03-10
• Results First Submitted QC: 2021-04-26
• Results First Posted: 2021-05-20
• Study Completion: 2022-07-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Histologically confirmed diagnosis of PTCL of the following subtypes: Nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (tumor cells must express 2 or 3 TFH-related antigens, including PD1, CD10, BCL6, CXCL13, ICOS, SAP and CCR5)* Angioimmunoblastic T-cell lymphoma Follicular T-cell lymphoma PTCL/NOS, T-follicular helper (TFH) variant PTCL-NOS Anaplastic large cell lymphoma, ALK negative Anaplastic large cell lymphoma, ALK positive with IPI > 2 Adult T-cell leukemia / lymphoma

• No prior systemic therapy for lymphoma
• Measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in two dimensions
• ECOG performance status ≤ 2

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Exclusion Criteria

• Known central nervous system (CNS) involvement by lymphoma
• Active viral infection with HIV or hepatitis type B or C (seropositive HBV patients are eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral therapy).
• Prior history of malignancies other than PTCL unless the patient has been disease free for ≥ 5 years from the signing of the ICF.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CC486 +CHOP	CC-486 Administration	CC486 +CHOP
CC486 +CHOP	CHOP Administration	CC486 +CHOP

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	After Cycle 6 at 18 weeks	Complete response rate (CR) of CC486-CHOP in PTCL by Lugano Criteria for target lesions, and the Deauville Criteria (5 point scale) assessed by PET or CT; CR (complete metabolic or radiologic response) defined as Deauville score of 1, 2 or 3 by PET or regression of all target lesions to \< 1.5cm in longest diameter by CT.

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Overall Survival	2 years	Overall Survival (OS) assessed by Kaplan-Meier survival analysis. The Kaplan-Meier overall survival estimate at 2 years (with 95% confidence interval) is reported.; OS defined as the time from first treatment day until death (or until last follow-up if alive).
Kaplan-Meier Progression-Free Survival	2 years	Progression-free survival (PFS) assessed by Kaplan-Meier survival analysis. The Kaplan-Meier progression-free survival estimate at 2 years (with 95% confidence interval) is reported.; PFS defined as the time from first treatment day until objective or symptomatic progression or death (or date of last follow-up if no progression/death).

Trial Locations

Locations (4)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States