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

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

Official Title
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Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma

Conditions
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Non-hodgkin Lymphoma, Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Chidamide
* Drug: Cladribine
* Drug: gemcitabine
* Drug: Busulfan
* Procedure: Autologous hematopoietic stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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 </= 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ChiCGB<br>Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. | Drug: Chidamide<br>* 30 mg oral twice weekly for 2 weeks<br>Drug: Cladribine<br>* 6 mg/m2 intravenously once daily for 5 days<br>Drug: gemcitabine<br>* 2500 mg/m2 intravenously twice weekly for 1 week<br>Drug: Busulfan<br>* 3.2 mg/kg intravenously once daily for 4 days<br>Procedure: Autologous hematopoietic stem cell transplantation<br>* autologous hematopoietic stem cells infusion after ChiCGB chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year progression free survival |  | 2 years from recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year overall survival |  | 2 years from recruitment | 
| Treatment related mortality |  | 2 years from recruitment | 
| non-hematologic adverse events |  | 2 years from recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chidamide, autologous stem cell transplantation