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ChiCGB vs BEAM in High-risk or R/R Lymphomas

NCT05466318 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2022-07-25

No results posted yet for this study

Summary

High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).

Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, T-Cell

Interventions

DRUG

Chidamide

30 mg oral twice weekly for 2 weeks

DRUG

Cladribine

6 mg/m2 intravenously once daily @ Day -7 \~ -3

DRUG

Gemcitabine

2500 mg/m2 intravenously @ Day -7, -3

DRUG

Busulfan

3.2 mg/kg intravenously once daily @ Day -7 \~ -4

DRUG

Carmustine

300 mg/m2 intravenously @ Day -8

DRUG

Etoposide

200 mg/m2 intravenously once daily @ Day -7 \~ -4

DRUG

Cytarabine

400 mg/m2 intravenously once daily @ Day -7 \~ -4

DRUG

Melphalan

140 mg/m2 intravenously @ Day -3

PROCEDURE

Autologous hematopoietic stem cell transplant

autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466318 on ClinicalTrials.gov