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Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

Primary Purpose

High-risk Aggressive Lymphoma After Auto-HSCT

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Maintenance therapy post-HSCT
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High-risk Aggressive Lymphoma After Auto-HSCT

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Rituximab maintenance

DPP/DCEP-G alternation regimen

Outcomes

Primary Outcome Measures

Relapse rate

Secondary Outcome Measures

Overall survival
Treatment-related mortality

Full Information

First Posted
October 2, 2018
Last Updated
October 2, 2018
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03695055
Brief Title
Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma
Official Title
Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-risk Aggressive Lymphoma After Auto-HSCT

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Rituximab maintenance
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
DPP/DCEP-G alternation regimen
Arm Title
Arm 3
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Maintenance therapy post-HSCT
Intervention Description
Rituximab vs DPP/DCEP-G vs observation
Primary Outcome Measure Information:
Title
Relapse rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Title
Treatment-related mortality
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Yang, Prof.
Phone
+86-591-83357896
Ext
8041
Email
yang.hopeting@gmail.com
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Prof.
Phone
+86-591-83357896
Ext
8041
Email
jdhu@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ting Yang, Prof.Dr.

12. IPD Sharing Statement

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Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

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