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

Primary Purpose

Hodgkin Lymphoma, Non-hodgkin Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Chidamide

Cladribine

gemcitabine

Busulfan

Autologous hematopoietic stem cell transplantation

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Chidamide, autologous stem cell transplantation

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ChiCGB

Arm Description

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

Outcomes

Primary Outcome Measures

2-year progression free survival

Secondary Outcome Measures

2-year overall survival

Treatment related mortality

non-hematologic adverse events

Full Information

NCT ID

NCT03602131

First Posted

July 17, 2018

Last Updated

July 25, 2018

Sponsor

Sichuan University

1. Study Identification

Unique Protocol Identification Number

NCT03602131

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Anticipated)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma, Non-hodgkin Lymphoma

Keywords

Chidamide, autologous stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ChiCGB

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chidamide

Intervention Description

30 mg oral twice weekly for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Cladribine

Intervention Description

6 mg/m2 intravenously once daily for 5 days

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Description

2500 mg/m2 intravenously twice weekly for 1 week

Intervention Type

Drug

Intervention Name(s)

Busulfan

Intervention Description

3.2 mg/kg intravenously once daily for 4 days

Intervention Type

Procedure

Intervention Name(s)

Autologous hematopoietic stem cell transplantation

Intervention Description

autologous hematopoietic stem cells infusion after ChiCGB chemotherapy

Primary Outcome Measure Information:

Title

2-year progression free survival

Time Frame

2 years from recruitment

Secondary Outcome Measure Information:

Title

2-year overall survival

Time Frame

2 years from recruitment

Title

Treatment related mortality

Time Frame

2 years from recruitment

Title

non-hematologic adverse events

Time Frame

2 years from recruitment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

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

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