Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ting YANG，Fujian Medical University

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

January 2014

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Relapse rate[ Time Frame: 2 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Overall survival[ Time Frame: 2 years ]
Treatment-related mortality[ Time Frame: 2 years ]

Descriptive Information

Brief Title ^ICMJE

Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2/Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Drug: Maintenance therapy post-HSCT
Rituximab vs DPP/DCEP-G vs observation

Study Arms

Experimental: Arm 1
Rituximab maintenance
Active Comparator: Arm 2
DPP/DCEP-G alternation regimen
No Intervention: Arm 3

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

January 2023

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

14 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ting YANG，Fujian Medical University

Study Sponsor ^ICMJE

Fujian Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Fujian Medical University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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