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
|Condition or disease||Intervention/treatment||Phase|
|Previously Untreated Peripheral T-cell Lymphoma||Drug: CC-486 Administration Drug: CHOP Administration||Phase 2|
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.
|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)|
|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|
Experimental: 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
- 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.
- 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.
- 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.
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
|Contact: Amelyn Rodriguez, RNfirstname.lastname@example.org|
|Contact: Rita Vaccaro, RNemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Rita Vaccaro, RN 212-746-0702 email@example.com|
|Principal Investigator:||Jia Ruan, MD, Ph.D||Weill Cornell Medicine|