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

NCT ID: NCT03602131

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-03-30

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.

Conditions

Hodgkin Lymphoma; Non-hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ChiCGB

Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

30 mg oral twice weekly for 2 weeks

Cladribine

Intervention Type: DRUG

6 mg/m2 intravenously once daily for 5 days

gemcitabine

Intervention Type: DRUG

2500 mg/m2 intravenously twice weekly for 1 week

Busulfan

Intervention Type: DRUG

3.2 mg/kg intravenously once daily for 4 days

Autologous hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

autologous hematopoietic stem cells infusion after ChiCGB chemotherapy

Interventions

Chidamide

30 mg oral twice weekly for 2 weeks

Intervention Type: DRUG

Cladribine

6 mg/m2 intravenously once daily for 5 days

Intervention Type: DRUG

gemcitabine

2500 mg/m2 intravenously twice weekly for 1 week

Intervention Type: DRUG

Busulfan

3.2 mg/kg intravenously once daily for 4 days

Intervention Type: DRUG

Autologous hematopoietic stem cell transplantation

autologous hematopoietic stem cells infusion after ChiCGB chemotherapy

Intervention Type: PROCEDURE

Eligibility 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 </= 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Jie Ji

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ChiCGB-HR lymphomas

Identifier Type: -

Identifier Source: org_study_id