Skip to content
Triangle logo TriangleGet started
← Study library

NCT03542266 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-08-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Complete Response Rate

→

outcome · POSTED

Kaplan-Meier Overall Survival

→

outcome · POSTED

Kaplan-Meier Progression-Free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
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.
healthy Volunteers
false
maximum Age
80 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    CC486 +CHOP
    intervention Names
    1. Drug: CC-486 Administration
    2. Drug: CHOP Administration
    label
    CC486 +CHOP
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. CC486 +CHOP
    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.
    name
    CC-486 Administration
    other Names
    1. Oral Azacitidine
    type
    DRUG
  2. arm Group Labels
    1. CC486 +CHOP
    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
    name
    CHOP Administration
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
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 Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
21
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Complete Response Rate
    time Frame
    After Cycle 6 at 18 weeks
secondary Outcomes
  1. 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).
    measure
    Kaplan-Meier Overall Survival
    time Frame
    2 years
  2. 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).
    measure
    Kaplan-Meier Progression-Free Survival
    time Frame
    2 years
Full 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.
Source references
references
  1. citation
    Ruan J, Moskowitz A, Mehta-Shah N, Sokol L, Chen Z, Kotlov N, Nos G, Sorokina M, Maksimov V, Sboner A, Sigouros M, van Besien K, Horwitz S, Rutherford SC, Mulvey E, Revuelta MV, Xiang J, Alonso A, Melnick A, Elemento O, Inghirami G, Leonard JP, Cerchietti L, Martin P. Multicenter phase 2 study of oral azacitidine (CC-486) plus CHOP as initial treatment for PTCL. Blood. 2023 May 4;141(18):2194-2205. doi: 10.1182/blood.2022018254.
    pmid
    36796016
    type
    DERIVED
  2. 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.
    pmid
    35995702
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-f3115f0a00d660571fed
      requested nct id
      NCT03542266
      primary nct id
      NCT03542266
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      cd286e7810b10ff06e62d1540c92d3444867e78fd98c4bf179aacfd95645e485
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-f3115f0a00d660571fed
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03542266
      occurrences
      1. context exact
        NCT03542266
        end
        11
        exact text
        NCT03542266
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/31/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2e5876c2cefd9d5f01bedafe034c058cd0149462d428d9d95439377b36581496

    Preserved source evidence · Not medical advice