Chidamide Combined With Clad/Gem/Bu With AutoSCT in High... | NCT03602131

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

NCT03602131

Sponsor

Sichuan University

Status

Unknown status

Last Update Posted

Jul 26, 2018Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Hodgkin Lymphoma
Non-hodgkin Lymphoma

Interventions

Chidamide
Cladribine
gemcitabine
Busulfan
Autologous hematopoietic stem cell transplantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Mar 30, 2021Estimated

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 25, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2018

Last Update Posted Date

Jul 26, 2018Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ChiCGB	Experimental	Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.	Drug: Chidamide Drug: Cladribine Drug: gemcitabine Drug: Busulfan Procedure: Autologous hematopoietic stem cell transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chidamide	Drug	30 mg oral twice weekly for 2 weeks	ChiCGB
Cladribine

Measure	Description	Time Frame
2-year progression free survival		2 years from recruitment

Measure	Description	Time Frame
2-year overall survival		2 years from recruitment
Treatment related mortality		2 years from recruitment
non-hematologic adverse events

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

ID	Term
C547816	N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide
D017338	Cladribine
D000093542	Gemcitabine
D002066	Busulfan

ID	Term
D015762	2-Chloroadenosine
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines