Clinical trial · Interventional

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

NCT03602131CI-TRIAL-00033996unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hodgkin Lymphoma	Hodgkin Lymphoma	ONTOLOGY_EXACT	0.90
Non-hodgkin Lymphoma	Non-Hodgkin Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Autologous hematopoietic stem cell transplantation	Procedure	—	UNRESOLVED
Busulfan	Drug	Busulfan	ALIAS
Chidamide	Drug	—	UNRESOLVED
Cladribine	Drug	Cladribine	ALIAS
gemcitabine	Drug	Gemcitabine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
ChiCGB
description
Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
interventionNames
1. Drug: Chidamide
2. Drug: Cladribine
3. Drug: gemcitabine
4. Drug: Busulfan
5. Procedure: Autologous hematopoietic stem cell transplantation

Primary outcomes (1)

measure
2-year progression free survival
timeFrame
2 years from recruitment

Secondary outcomes (3)

measure
2-year overall survival
timeFrame
2 years from recruitment

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 15 Years
Maximum age: 65 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.