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

Sponsor
Sichuan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03602131
Collaborator
(none)
30
1
26.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ChiCGB

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

Drug: Chidamide
30 mg oral twice weekly for 2 weeks

Drug: Cladribine
6 mg/m2 intravenously once daily for 5 days

Drug: gemcitabine
2500 mg/m2 intravenously twice weekly for 1 week

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. 2-year progression free survival [2 years from recruitment]

Secondary Outcome Measures

  1. 2-year overall survival [2 years from recruitment]

  2. Treatment related mortality [2 years from recruitment]

  3. non-hematologic adverse events [2 years from recruitment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sichuan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Ji, Clinical Professor, Sichuan University
ClinicalTrials.gov Identifier:
NCT03602131
Other Study ID Numbers:
  • ChiCGB-HR lymphomas
First Posted:
Jul 26, 2018
Last Update Posted:
Jul 26, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jie Ji, Clinical Professor, Sichuan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2018