Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
This study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ChiCGB Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. |
Drug: Chidamide
30 mg oral twice weekly for 2 weeks
Drug: Cladribine
6 mg/m2 intravenously once daily for 5 days
Drug: gemcitabine
2500 mg/m2 intravenously twice weekly for 1 week
Drug: Busulfan
3.2 mg/kg intravenously once daily for 4 days
Procedure: Autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cells infusion after ChiCGB chemotherapy
|
Outcome Measures
Primary Outcome Measures
- 2-year progression free survival [2 years from recruitment]
Secondary Outcome Measures
- 2-year overall survival [2 years from recruitment]
- Treatment related mortality [2 years from recruitment]
- non-hematologic adverse events [2 years from recruitment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
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Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
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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.
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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.
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Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
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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:
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Central nervous system lymphoma
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Patients relapsed after autologous stem cell transplantation
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Bone marrow was involved by lymphoma
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Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
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Active infection requiring parenteral antibiotics
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HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts
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Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
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Patients with a corrected QT interval(QTc) longer than 500 ms
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sichuan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChiCGB-HR lymphomas