Comparing two chemotherapy regimens for high-risk lymphomas
ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial
PHASE3 · Sichuan University · NCT05466318
This study is testing a new chemotherapy treatment called ChiCGB to see if it works better than the standard BEAM treatment for people with high-risk lymphomas before they have a stem cell transplant.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 306 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Sichuan University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 11 sites (Deyang, Deyang and 10 other locations) |
| Trial ID | NCT05466318 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a new chemotherapy regimen called ChiCGB, which includes chidamide, cladribine, gemcitabine, and busulfan, against the standard BEAM regimen in patients with high-risk or relapsed/refractory lymphomas. Participants will be randomized to receive either ChiCGB or BEAM as part of their treatment before undergoing autologous stem cell transplantation. The study will follow patients for up to two years post-transplant to assess survival outcomes and overall effectiveness of the treatments.
Who should consider this trial
Good fit: Ideal candidates include patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma who have responded to prior salvage chemotherapy.
Not a fit: Patients who do not respond to salvage chemotherapy or those with significant comorbidities affecting organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with high-risk lymphomas.
How similar studies have performed: Previous studies have shown promising results with similar chemotherapy regimens, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Deyang, Deyang and 10 other locations
- People's Hospital of Deyang City — Deyang, Deyang, China (NOT_YET_RECRUITING)
- Chengdu Third People's Hospital — Chendu, Sichuan, China (NOT_YET_RECRUITING)
- West China Hospital, Sichuan University — Chendu, Sichuan, China (RECRUITING)
- Chengdu First People's Hospital — Chengdu, Sichuan, China (RECRUITING)
- PLA Western Theater Command General Hospital — Chengdu, Sichuan, China (RECRUITING)
- Dazhou Central Hospital — Dazhou, Sichuan, China (NOT_YET_RECRUITING)
- Southwest Medical University — Luzhou, Sichuan, China (RECRUITING)
- Central Hospital of Mianyang City — Mianyang, Sichuan, China (RECRUITING)
- Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (NOT_YET_RECRUITING)
- Zigong First People's Hospital — Zigong, Sichuan, China (RECRUITING)
- Guangyuan Central Hospital — Guangyuan, Sihcuan, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell