Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Fujian Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: High-risk Aggressive Lymphoma After Auto-HSCT

Treatments: Drug: Maintenance therapy post-HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT03695055

Lym-SCT-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Arm 1

Experimental group

Description:

Rituximab maintenance

Treatment:

Drug: Maintenance therapy post-HSCT

Arm 2

Active Comparator group

Description:

DPP/DCEP-G alternation regimen

Treatment:

Drug: Maintenance therapy post-HSCT

Arm 3

No Intervention group