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Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Sponsor
Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03695055
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
108
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Maintenance therapy post-HSCT
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma
Actual Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Rituximab maintenance

Drug: Maintenance therapy post-HSCT
Rituximab vs DPP/DCEP-G vs observation
Active Comparator: Arm 2

DPP/DCEP-G alternation regimen

Drug: Maintenance therapy post-HSCT
Rituximab vs DPP/DCEP-G vs observation
No Intervention: Arm 3

Outcome Measures

Primary Outcome Measures

  1. Relapse rate [2 years]

Secondary Outcome Measures

  1. Overall survival [2 years]

  2. Treatment-related mortality [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Medical University Union Hospital Fuzhou Fujian China 350001

Sponsors and Collaborators

  • Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ting YANG, Prof.M.D.Ph.D, Fujian Medical University
ClinicalTrials.gov Identifier:
NCT03695055
Other Study ID Numbers:
  • Lym-SCT-001
First Posted:
Oct 3, 2018
Last Update Posted:
Oct 3, 2018
Last Verified:
Oct 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Aggression

Study Results

No Results Posted as of Oct 3, 2018