Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03695055

Enrollment

Registered

2018-10-03

Start date

2014-01-31

Completion date

2023-01-31

Last updated

2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Aggressive Lymphoma After Auto-HSCT

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.

Interventions

DRUGMaintenance therapy post-HSCT

Rituximab vs DPP/DCEP-G vs observation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Relapse rate	2 years

Secondary

Measure	Time frame
Overall survival	2 years
Treatment-related mortality	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026