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Efficacy and Safety of Decitabine Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

Primary Purpose

Peripheral T-cell Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Decitabine
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Peripheral T-cell Lymphoma, decitabine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anapestic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype and Follicular T-cell lymphoma).
  2. Males and females of 18 years of age to 80 years of age.
  3. Patients have not received anti-tumor therapy.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  5. Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.
  6. Normal peripheral hemogram: ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^12/L.
  7. None of other serious disease conflict with the therapeutic regimen.
  8. None of other malignant tumor.
  9. Pregnancy test of women at reproductive age must be negative.
  10. Estimated survival time ≥ 3 months with good compliance.
  11. Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.

Exclusion Criteria:

  1. Patients with the following PTCL subtypes are excluded; extranodal NNK/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive natural killer-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
  2. Transformed lymphoma.
  3. Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
  4. Already initiated lymphoma therapy (exept for the prephase treatment specified for this study).
  5. Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
  6. Patients who have central nervous system or meninges involvements.
  7. Candidate for hematopoietic stem cell transplantation.
  8. Known hypersensitivity to medications to be used.
  9. Hemogram abnormality: ANC<1.5×10^9/L; or HGB<90 g/L; or PLT<100×10^9/L.
  10. Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
  11. Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months.
  12. Patients with serious uncontroled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
  13. Know HIV-positivity; or HbsAg positivity; or HCV-Ab positivity.
  14. Pregnancy or lactation period.
  15. Patients who participated in other clinical trials within 3 months.
  16. The researchers considered that patients should not be in this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Decitabine + CHOP regimen

    CHOP regimen

    Arm Description

    decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles

    cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles

    Outcomes

    Primary Outcome Measures

    Progression Free Survival
    from date of inclusion to date of progression, relapse, or death from any cause

    Secondary Outcome Measures

    Overall Survival
    from the date of inclusion to date of death, irrespective of cause
    Response rate
    complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
    Adverse Events
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

    Full Information

    First Posted
    May 30, 2018
    Last Updated
    May 30, 2018
    Sponsor
    Southwest Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03553537
    Brief Title
    Efficacy and Safety of Decitabine Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
    Official Title
    Multi-center Randomized Study to Compare Efficacy and Safety of Decitabine Plus CHOP (D-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southwest Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Primary objective of the study is to compare the efficacy and safety of decitabine plus CHOP (D-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL).
    Detailed Description
    This is a randomized, multi-center, open-label study to compare efficacy and safety of D-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles. In the D-CHOP arm, decitabine will be administered at a dose of 10 mg/m² IV on day 1-5 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal.Adverse event of every treatment cycle will be recorded.Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral T-cell Lymphoma
    Keywords
    Peripheral T-cell Lymphoma, decitabine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Decitabine + CHOP regimen
    Arm Type
    Experimental
    Arm Description
    decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles
    Arm Title
    CHOP regimen
    Arm Type
    Active Comparator
    Arm Description
    cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Decitabine
    Other Intervention Name(s)
    5-aza-2'-deoxycytidine
    Intervention Description
    10mg/m² iv on day 1-5
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Other Intervention Name(s)
    CTX
    Intervention Description
    750mg/m² iv on day 6
    Intervention Type
    Drug
    Intervention Name(s)
    Doxorubicin
    Other Intervention Name(s)
    50mg/m² iv on day 6
    Intervention Description
    DOX
    Intervention Type
    Drug
    Intervention Name(s)
    Vincristine
    Other Intervention Name(s)
    VCR
    Intervention Description
    1.4mg/m² iv on day 6
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Other Intervention Name(s)
    PED
    Intervention Description
    100mg/m² po on day6-10
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    Description
    from date of inclusion to date of progression, relapse, or death from any cause
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Overall Survival
    Description
    from the date of inclusion to date of death, irrespective of cause
    Time Frame
    3 years
    Title
    Response rate
    Description
    complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
    Time Frame
    3 years
    Title
    Adverse Events
    Description
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
    Time Frame
    3 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: Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anapestic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype and Follicular T-cell lymphoma). Males and females of 18 years of age to 80 years of age. Patients have not received anti-tumor therapy. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN. Normal peripheral hemogram: ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^12/L. None of other serious disease conflict with the therapeutic regimen. None of other malignant tumor. Pregnancy test of women at reproductive age must be negative. Estimated survival time ≥ 3 months with good compliance. Voluntary participation, cooperate with the experimental observation, and sign a written informed consent. Exclusion Criteria: Patients with the following PTCL subtypes are excluded; extranodal NNK/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive natural killer-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma. Transformed lymphoma. Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies. Already initiated lymphoma therapy (exept for the prephase treatment specified for this study). Patients with primary central nervous system lymphoma or lymphoma involving central nervous system. Patients who have central nervous system or meninges involvements. Candidate for hematopoietic stem cell transplantation. Known hypersensitivity to medications to be used. Hemogram abnormality: ANC<1.5×10^9/L; or HGB<90 g/L; or PLT<100×10^9/L. Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN). Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months. Patients with serious uncontroled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function. Know HIV-positivity; or HbsAg positivity; or HCV-Ab positivity. Pregnancy or lactation period. Patients who participated in other clinical trials within 3 months. The researchers considered that patients should not be in this trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jieping Chen, MD
    Phone
    +86 13983766908
    Email
    chenjpxn@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xi Li, MD
    Phone
    +86 15223038417
    Email
    lixi1988xn@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jieping Chen, MD,PhD
    Organizational Affiliation
    Southwest Hospital, China
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xi Li, MD
    Organizational Affiliation
    Southwest Hospital, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy and Safety of Decitabine Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

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