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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03602131

Enrollment

Registered

2018-07-26

Start date

2019-01-01

Completion date

2021-03-30

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma, Non-hodgkin Lymphoma

Keywords

Chidamide, autologous stem cell transplantation

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.

Interventions

DRUGChidamide

30 mg oral twice weekly for 2 weeks

DRUGCladribine

6 mg/m2 intravenously once daily for 5 days

DRUGgemcitabine

2500 mg/m2 intravenously twice weekly for 1 week

DRUGBusulfan

3.2 mg/kg intravenously once daily for 4 days

PROCEDUREAutologous hematopoietic stem cell transplantation

autologous hematopoietic stem cells infusion after ChiCGB chemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
2-year progression free survival	2 years from recruitment

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026