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

Launched by SICHUAN UNIVERSITY · Jul 17, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment methods for patients with high-risk or relapsed lymphoma, specifically looking at a new combination therapy called ChiCGB, which includes chidamide, cladribine, gemcitabine, and busulfan, against a standard treatment known as BEAM (which includes BCNU, etoposide, cytarabine, and melphalan). The goal is to determine if ChiCGB can improve survival rates for patients with conditions like diffuse large B-cell lymphoma or extra-nodal NK/T-cell lymphoma, who may not have responded well to previous treatments.

To participate in this trial, patients should have a history of either primary refractory or recurrent lymphoma and must have shown some response to prior treatments. Other important health criteria include having good kidney, liver, lung, and heart function. Those who join the trial will be randomly assigned to receive either ChiCGB or BEAM, and their health will be monitored for up to two years after receiving stem cell transplantation. This study is actively recruiting participants and aims to provide valuable insights into improving treatment options for lymphoma patients.

Gender

ALL

Eligibility criteria

• 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