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

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ClinicalTrials.gov Identifier: NCT03542266
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Previously Untreated Peripheral T-cell Lymphoma Drug: CC-486 Administration Drug: CHOP Administration Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study of CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: CC486 +CHOP
CC486 +CHOP
Drug: CC-486 Administration
CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
Other Name: Oral Azacitidine

Drug: CHOP Administration

CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:

Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5





Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: After Cycle 6 at 18 weeks ]
    Complete response rate (CR) of CC486-CHOP in PTCL by 2014 International Working Group (IWG) criteria, and the Deauville Criteria for scan interpretation.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]

    Overall Survival (OS) assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.

    OS will be defined as the time from first treatment day until death.


  2. Progression-Free Survival [ Time Frame: 2 years ]

    Progression-free survival (PFS), assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.

    PFS will be defined as the time from first treatment day until objective or symptomatic progression or death.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of PTCL of the following subtypes:

    1. Angioimmunoblastic T-cell lymphoma
    2. Follicular T-cell lymphoma
    3. PTCL/NOS, T-follicular helper (TFH) variant
  • 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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542266


Contacts
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Contact: Amelyn Rodriguez, RN 2127461362 amr2017@med.cornell.edu
Contact: Rita Vaccaro, RN 2127460702 rig9021@med.cornell.edu

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Lubomir Sokol, MD, PhD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Neha Mehta-Shah, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alison Moskowitz, MD         
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Amelyn Rodriguez, RN    212-746-1362    amr2017@med.cornell.edu   
Contact: Rita Vaccaro, RN    212-746-0702    rig9021@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Celgene Corporation
Investigators
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Principal Investigator: Jia Ruan, MD, Ph.D Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03542266     History of Changes
Other Study ID Numbers: 1711018777
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Peripheral T-cell Lymphoma
Azacitidine
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors