High-risk Aggressive Lymphoma After Auto-HSCT Clinical Trial
Official title:
Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma
| Verified date | October 2018 |
| Source | Fujian Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | January 2023 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 14 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
| Lead Sponsor | Collaborator |
|---|---|
| Fujian Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relapse rate | 2 years | ||
| Secondary | Overall survival | 2 years | ||
| Secondary | Treatment-related mortality | 2 years |