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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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ClinicalTrials.gov Identifier: NCT03553537
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jieping Chen, Southwest Hospital, China

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).

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Decitabine Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: Decitabine + CHOP regimen
decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles
Drug: Decitabine
10mg/m² iv on day 1-5
Other Name: 5-aza-2'-deoxycytidine

Drug: Cyclophosphamide
750mg/m² iv on day 6
Other Name: CTX

Drug: Doxorubicin
DOX
Other Name: 50mg/m² iv on day 6

Drug: Vincristine
1.4mg/m² iv on day 6
Other Name: VCR

Drug: Prednisone
100mg/m² po on day6-10
Other Name: PED

Active Comparator: CHOP regimen
cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles
Drug: Cyclophosphamide
750mg/m² iv on day 6
Other Name: CTX

Drug: Doxorubicin
DOX
Other Name: 50mg/m² iv on day 6

Drug: Vincristine
1.4mg/m² iv on day 6
Other Name: VCR

Drug: Prednisone
100mg/m² po on day6-10
Other Name: PED




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 3 years ]
    from date of inclusion to date of progression, relapse, or death from any cause


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
    from the date of inclusion to date of death, irrespective of cause

  2. Response rate [ Time Frame: 3 years ]
    complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)

  3. Adverse Events [ Time Frame: 3 years ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT03553537


Contacts
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Contact: Jieping Chen, MD +86 13983766908 chenjpxn@163.com
Contact: Xi Li, MD +86 15223038417 lixi1988xn@163.com

Sponsors and Collaborators
Southwest Hospital, China
Investigators
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Principal Investigator: Jieping Chen, MD,PhD Southwest Hospital, China
Principal Investigator: Xi Li, MD Southwest Hospital, China

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Responsible Party: Jieping Chen, Head of Hematology Department, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03553537     History of Changes
Other Study ID Numbers: D-CHOP study
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jieping Chen, Southwest Hospital, China:
Peripheral T-cell Lymphoma, decitabine
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Vincristine
Decitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents