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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03602131
• Other study ID #: ChiCGB-HR lymphomas
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2018
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma

Intervention

Drug:
• Chidamide
30 mg oral twice weekly for 2 weeks
• Cladribine
6 mg/m2 intravenously once daily for 5 days
• gemcitabine
2500 mg/m2 intravenously twice weekly for 1 week
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year progression free survival		2 years from recruitment
Secondary	2-year overall survival		2 years from recruitment
Secondary	Treatment related mortality		2 years from recruitment
Secondary	non-hematologic adverse events		2 years from recruitment