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

NCT05466318 | Unknown Phase 3

• 1 other identifier: ChiCGB 2.0
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 11

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression free survival of this group of patients at the end of 2 year

  2 years

Secondary Outcomes (3)

• Overall survival (OS)

  2 years

• 100 day adverse events (AE)

  100 days from transplant

• 100 day complete response (CR) rate

  100 days from transplant

Study Arms (2)

ChiCGB

EXPERIMENTAL

Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.

Drug: Chidamide; Drug: Cladribine; Drug: Gemcitabine; Drug: Busulfan; Procedure: Autologous hematopoietic stem cell transplant

BEAM

ACTIVE COMPARATOR

Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.

Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Procedure: Autologous hematopoietic stem cell transplant

Interventions

Chidamide DRUG

30 mg oral twice weekly for 2 weeks

ChiCGB

Cladribine DRUG

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

ChiCGB

Gemcitabine DRUG

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

ChiCGB

Busulfan DRUG

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

ChiCGB

Carmustine DRUG

300 mg/m2 intravenously @ Day -8

BEAM

Etoposide DRUG

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

BEAM

Cytarabine DRUG

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

BEAM

Melphalan DRUG

140 mg/m2 intravenously @ Day -3

BEAM

Autologous hematopoietic stem cell transplant PROCEDURE

autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy

BEAM; ChiCGB

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (11)

People's Hospital of Deyang City

Deyang, Deyang, 618000, China

NOT YET RECRUITING

Chengdu Third People's Hospital

Chengdu, Sichuan, 610015, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Chengdu First People's Hospital

Chengdu, Sichuan, 610071, China

RECRUITING

PLA Western Theater Command General Hospital

Chengdu, Sichuan, 610083, China

RECRUITING

Dazhou Central Hospital

Dazhou, Sichuan, 635000, China

NOT YET RECRUITING

Southwest Medical University

Luzhou, Sichuan, 646000, China

RECRUITING

Central Hospital of Mianyang City

Mianyang, Sichuan, 621000, China

RECRUITING

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

NOT YET RECRUITING

Zigong First People's Hospital

Zigong, Sichuan, 643011, China

RECRUITING

Guangyuan Central Hospital

Guangyuan, Sihcuan, 628099, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cladribine; Gemcitabine; Busulfan; Carmustine; Etoposide; Cytarabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma, B-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)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Arabinonucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

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: Principle Investigator

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 20, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the publication of results of this trial

Locations

CN (11)