Clinical trial · Interventional
Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma
Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma
NCT03695055CI-TRIAL-00035135unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Aggressive Lymphoma After Auto-HSCT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maintenance therapy post-HSCT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Rituximab maintenance
- interventionNames
- Drug: Maintenance therapy post-HSCT
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- DPP/DCEP-G alternation regimen
- interventionNames
- Drug: Maintenance therapy post-HSCT
- type
- NO_INTERVENTION
- label
- Arm 3
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.