CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/3/2018 |
| Start Date: | June 1, 2018 |
| End Date: | May 30, 2022 |
| Contact: | Amelyn Rodriguez, RN |
| Email: | amr2017@med.cornell.edu |
| Phone: | 2127461362 |
A Multi-center Phase II Study of CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
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.
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.
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.
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.
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.
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