Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma

• Status: Unknown status
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan University
• Treatments: Busulfan; Cladribine; Gemcitabine

Criteria

Inclusion Criteria:

• Patients with primary refractory or recurrent diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T cell lymphomas, Hodgkin lymphomas 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
• Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT)normal; serum bilirubin and alkaline phosphatase
• 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