Back to resultsCC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Primary Purpose
Previously Untreated Peripheral T-cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-486 Administration
CHOP Administration
Sponsored by
About this trial
This is an interventional treatment trial for Previously Untreated Peripheral T-cell Lymphoma focused on measuring Peripheral T-cell Lymphoma, Azacitidine, Lymphoma
Eligibility Criteria
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
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.
Sites / Locations
- Moffitt Cancer Center
- Washington University School of Medicine
- Memorial Sloan Kettering Cancer Center
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CC486 +CHOP
Arm Description
CC486 +CHOP
Outcomes
Primary Outcome Measures
Complete Response Rate
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
Kaplan-Meier Overall Survival
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
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).
Full Information
NCT ID
NCT03542266
First Posted
May 18, 2018
Last Updated
July 28, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03542266
Brief Title
CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Official Title
A Multi-center Phase II Study of CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
July 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Celgene Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previously Untreated Peripheral T-cell Lymphoma
Keywords
Peripheral T-cell Lymphoma, Azacitidine, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CC486 +CHOP
Arm Type
Experimental
Arm Description
CC486 +CHOP
Intervention Type
Drug
Intervention Name(s)
CC-486 Administration
Other Intervention Name(s)
Oral Azacitidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CHOP Administration
Intervention Description
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 Measure Information:
Title
Complete Response Rate
Description
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.
Time Frame
After Cycle 6 at 18 weeks
Secondary Outcome Measure Information:
Title
Kaplan-Meier Overall Survival
Description
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).
Time Frame
2 years
Title
Kaplan-Meier Progression-Free Survival
Description
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).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Ruan, MD, Ph.D
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35995702
Citation
Yoon SE, Cho J, Kim YJ, Kim SJ, Kim WS. Real-World Efficacy of 5-Azacytidine as Salvage Chemotherapy for Angioimmunoblastic T-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):e972-e980. doi: 10.1016/j.clml.2022.07.009. Epub 2022 Jul 17.
Results Reference
derived
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CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
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