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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466318
• Other study ID #: ChiCGB 2.0
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2022
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Chidamide
30 mg oral twice weekly for 2 weeks
• Cladribine
6 mg/m2 intravenously once daily @ Day -7 ~ -3
• Gemcitabine
2500 mg/m2 intravenously @ Day -7, -3
• Busulfan
3.2 mg/kg intravenously once daily @ Day -7 ~ -4
• Carmustine
300 mg/m2 intravenously @ Day -8
• Etoposide
200 mg/m2 intravenously once daily @ Day -7 ~ -4
• Cytarabine
400 mg/m2 intravenously once daily @ Day -7 ~ -4
• Melphalan
140 mg/m2 intravenously @ Day -3

Procedure:
• Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy

Locations

Country	Name	City	State
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	People's Hospital of Deyang City	Deyang	Deyang
China	Guangyuan Central Hospital	Guangyuan	Sihcuan
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

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Progression free survival of this group of patients at the end of 2 year	2 years
Secondary	Overall survival (OS)	Overall survival of this group of patients at the end of 2 year	2 years
Secondary	100 day adverse events (AE)	non-hematologic adverse events @ Day +100	100 days from transplant
Secondary	100 day complete response (CR) rate	Complete response @ Day +100	100 days from transplant