Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma

Conditions
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High-risk Aggressive Lymphoma After Auto-HSCT

Intervention / Treatment
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* Drug: Maintenance therapy post-HSCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Rituximab maintenance | Drug: Maintenance therapy post-HSCT<br>* Rituximab vs DPP/DCEP-G vs observation<br>|
| Active Comparator: Arm 2<br>DPP/DCEP-G alternation regimen | Drug: Maintenance therapy post-HSCT<br>* Rituximab vs DPP/DCEP-G vs observation<br>|
| No Intervention: Arm 3<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 
| Treatment-related mortality |  | 2 years |