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

Phase 3

Recruiting

• Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell
• Interventions: Drug: Chidamide; Drug: Carmustine; Drug: Cladribine; Drug: Etoposide; Drug: Gemcitabine; Drug: Cytarabine; Drug: Busulfan; Drug: Melphalan; Procedure: Autologous hematopoietic stem cell transplant

• Registration Number: NCT05466318
• Lead Sponsor: Sichuan University

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-01
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-20
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
• Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
• Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
• Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
• Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin.
• Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• Performance status 0-1. 10. Negative Beta diffusing capacity of the lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria

• Central nervous system lymphoma
• Patients relapsed after autologous stem cell transplantation
• Bone marrow was involved by lymphoma
• Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
• Active infection requiring parenteral antibiotics
• HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts
• Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
• Patients with a corrected QT interval(QTc) longer than 500 ms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChiCGB	Cladribine	Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
BEAM	Autologous hematopoietic stem cell transplant	Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
ChiCGB	Autologous hematopoietic stem cell transplant	Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
ChiCGB	Gemcitabine	Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
ChiCGB	Chidamide	Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
BEAM	Etoposide	Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
ChiCGB	Busulfan	Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
BEAM	Carmustine	Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
BEAM	Cytarabine	Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
BEAM	Melphalan	Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years	Progression free survival of this group of patients at the end of 2 year

Secondary Outcome Measures

Name	Time	Method
100 day adverse events (AE)	100 days from transplant	non-hematologic adverse events @ Day +100
100 day complete response (CR) rate	100 days from transplant	Complete response @ Day +100
Overall survival (OS)	2 years	Overall survival of this group of patients at the end of 2 year

Trial Locations

Locations (11)

People's Hospital of Deyang City; 🇨🇳 Deyang, Deyang, China

Chengdu Third People's Hospital; 🇨🇳 Chendu, Sichuan, China

West China Hospital, Sichuan University; 🇨🇳 Chendu, Sichuan, China

Chengdu First People's Hospital; 🇨🇳 Chengdu, Sichuan, China

PLA Western Theater Command General Hospital; 🇨🇳 Chengdu, Sichuan, China

Dazhou Central Hospital; 🇨🇳 Dazhou, Sichuan, China

Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China

Central Hospital of Mianyang City; 🇨🇳 Mianyang, Sichuan, China

Affiliated Hospital of North Sichuan Medical College; 🇨🇳 Nanchong, Sichuan, China

Zigong First People's Hospital; 🇨🇳 Zigong, Sichuan, China

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