Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma
Phase 2
- Conditions
- High-risk Aggressive Lymphoma After Auto-HSCT
- Interventions
- Drug: Maintenance therapy post-HSCT
- Registration Number
- NCT03695055
- Lead Sponsor
- Fujian Medical University
- Brief Summary
Relapse after autologous hematopoietic stem cell transplantation (ASCT) is still challenging for high-risk aggressive lymphoma. This study was to investigate the efficacy and safety of maintenance therapy post-ASCT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Age 14-70 years
- High-risk aggressive lymphoma underwent auto-HSCT
- Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate hematological function
- Offer informed consent
Exclusion Criteria
- Concomitant other cancer
- Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
- Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
- Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
- Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea > 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
- Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Maintenance therapy post-HSCT Rituximab maintenance Arm 2 Maintenance therapy post-HSCT DPP/DCEP-G alternation regimen
- Primary Outcome Measures
Name Time Method Relapse rate 2 years
- Secondary Outcome Measures
Name Time Method Overall survival 2 years Treatment-related mortality 2 years
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China