Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma
| Registry | NCT03602131 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Sichuan University (Other) |
| Conditions | Hodgkin Lymphoma, Non-hodgkin Lymphoma |
| Interventions | Chidamide, Cladribine, gemcitabine, Busulfan, Autologous hematopoietic stem cell transplantation (Drug, procedure) |
| Dates | start 2019-01-01 (estimated), primary completion 2020-12-30 (estimated), completion 2021-03-30 (estimated), first posted 2018-07-26, last updated 2018-07-26 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ChiCGB | Experimental | Drug: Chidamide; Drug: Cladribine; Drug: gemcitabine; Drug: Busulfan; Procedure: Autologous hematopoietic stem cell transplantation | Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. |
Sex: All, ages: 15 Years to 65 Years
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