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

NCT03553537 | Unknown Phase 3 DMC

• 1 other identifier: D-CHOP study
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Peripheral T-cell Lymphoma

Keywords

Peripheral T-cell Lymphoma, decitabine

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

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

  3 years

Secondary Outcomes (3)

• Overall Survival

  3 years

• Response rate

  3 years

• Adverse Events

  3 years

Study Arms (2)

Decitabine + CHOP regimen

EXPERIMENTAL

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

Drug: Decitabine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

CHOP regimen

ACTIVE COMPARATOR

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

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Decitabine DRUG

10mg/m² iv on day 1-5

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

Decitabine + CHOP regimen

Cyclophosphamide DRUG

750mg/m² iv on day 6

Also known as: CTX

CHOP regimen; Decitabine + CHOP regimen

Doxorubicin DRUG

DOX

Also known as: 50mg/m² iv on day 6

CHOP regimen; Decitabine + CHOP regimen

Vincristine DRUG

1.4mg/m² iv on day 6

Also known as: VCR

CHOP regimen; Decitabine + CHOP regimen

Prednisone DRUG

100mg/m² po on day6-10

Also known as: PED

CHOP regimen; Decitabine + CHOP regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Decitabine; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Jieping Chen, MD,PhD

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

• Xi Li, MD

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieping Chen, MD

CONTACT

+86 13983766908; chenjpxn@163.com

Xi Li, MD

CONTACT

+86 15223038417; lixi1988xn@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology Department

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: June 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 12, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share