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Status unknownNCT03553537Updated Jun 12, 2018

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

A Phase 3 interventional study of Decitabine and Cyclophosphamide in Peripheral T-cell Lymphoma, sponsored by Southwest Hospital, China. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by Southwest Hospital, China · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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).

Read the 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.

02

Conditions studied

  • Peripheral T-cell Lymphoma

Keywords

  • Peripheral T-cell Lymphoma, decitabine
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In context

Lymphoma

5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 4,507 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Decitabine + CHOP regimen

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

    Drug: Decitabine · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone

  • Active comparator
    CHOP regimen

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

    Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone

Interventions

  • DrugDecitabine

    10mg/m² iv on day 1-5

    Also known as: 5-aza-2'-deoxycytidine

  • DrugCyclophosphamide

    750mg/m² iv on day 6

    Also known as: CTX

  • DrugDoxorubicin

    DOX

    Also known as: 50mg/m² iv on day 6

  • DrugVincristine

    1.4mg/m² iv on day 6

    Also known as: VCR

  • DrugPrednisone

    100mg/m² po on day6-10

    Also known as: PED

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

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

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival

    from the date of inclusion to date of death, irrespective of cause

    Time frame: 3 years

  2. Response rate

    complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)

    Time frame: 3 years

  3. 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

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03553537
Lead sponsor
Southwest Hospital, China
Responsible party
Jieping Chen (Head of Hematology Department, Southwest Hospital, China) — Principal investigator
First posted
Jun 12, 2018
Start date
Jun 2018 (estimated)
Primary completion
Jul 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jun 12, 2018

Study contacts

Jieping Chen, MD
Contact
chenjpxn@163.com
+86 13983766908
Xi Li, MD
Contact
lixi1988xn@163.com
+86 15223038417
Jieping Chen, MD,PhD
principal investigator · Southwest Hospital, China
Xi Li, MD
principal investigator · Southwest Hospital, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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