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

S

Sichuan University

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Drug: Cladribine
Drug: Cytarabine
Drug: Melphalan
Drug: Chidamide
Drug: Gemcitabine
Drug: Carmustine
Procedure: Autologous hematopoietic stem cell transplant
Drug: Busulfan
Drug: Etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT05466318
ChiCGB 2.0

Details and patient eligibility

About

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).

Enrollment

306 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

306 participants in 2 patient groups

ChiCGB
Experimental group
Description:
Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
Treatment:
Drug: Busulfan
Procedure: Autologous hematopoietic stem cell transplant
Drug: Cladribine
Drug: Chidamide
Drug: Gemcitabine
BEAM
Active Comparator group
Description:
Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
Treatment:
Drug: Cytarabine
Drug: Etoposide
Drug: Carmustine
Drug: Melphalan
Procedure: Autologous hematopoietic stem cell transplant

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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