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ChiCGB vs BEAM in High-risk or R/R Lymphomas

Sponsor
Sichuan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05466318
Collaborator
(none)
306
Enrollment
11
Locations
2
Arms
42
Anticipated Duration (Months)
27.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Dec 30, 2025

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 @ Day -7 ~ -3

Drug: Gemcitabine
2500 mg/m2 intravenously @ Day -7, -3

Drug: Busulfan
3.2 mg/kg intravenously once daily @ Day -7 ~ -4

Procedure: Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
Active Comparator: BEAM

Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.

Drug: Carmustine
300 mg/m2 intravenously @ Day -8

Drug: Etoposide
200 mg/m2 intravenously once daily @ Day -7 ~ -4

Drug: Cytarabine
400 mg/m2 intravenously once daily @ Day -7 ~ -4

Drug: Melphalan
140 mg/m2 intravenously @ Day -3

Procedure: Autologous hematopoietic stem cell transplant
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy

Outcome Measures

Primary Outcome Measures

  1. Progression free survival (PFS) [2 years]

    Progression free survival of this group of patients at the end of 2 year

Secondary Outcome Measures

  1. Overall survival (OS) [2 years]

    Overall survival of this group of patients at the end of 2 year

  2. 100 day adverse events (AE) [100 days from transplant]

    non-hematologic adverse events @ Day +100

  3. 100 day complete response (CR) rate [100 days from transplant]

    Complete response @ Day +100

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 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 or extra-nodal NK/T cell lymphoma 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

Site City State Country Postal Code
1 People's Hospital of Deyang City Deyang Deyang China 618000
2 Chengdu Third People's Hospital Chendu Sichuan China 610015
3 West China Hospital, Sichuan University Chendu Sichuan China 610041
4 Chengdu First People's Hospital Chengdu Sichuan China 610071
5 PLA Western Theater Command General Hospital Chengdu Sichuan China 610083
6 Dazhou Central Hospital Dazhou Sichuan China 635000
7 Southwest Medical University Luzhou Sichuan China 646000
8 Central Hospital of Mianyang City Mianyang Sichuan China 621000
9 Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan China 637000
10 Zigong First People's Hospital Zigong Sichuan China 643011
11 Guangyuan Central Hospital Guangyuan Sihcuan China 628099

Sponsors and Collaborators

  • Sichuan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Ji, Principle Investigator, Sichuan University
ClinicalTrials.gov Identifier:
NCT05466318
Other Study ID Numbers:
  • ChiCGB 2.0
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Gemcitabine
Cytarabine
Etoposide
Melphalan
Busulfan
Carmustine
Cladribine

Study Results

No Results Posted as of Jul 25, 2022