Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma

NCT ID: NCT03695055

Last Updated: 2018-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2023-01-31

Brief Summary

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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

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Conditions

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High-risk Aggressive Lymphoma After Auto-HSCT

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Rituximab maintenance

Group Type EXPERIMENTAL

Maintenance therapy post-HSCT

Intervention Type DRUG

Rituximab vs DPP/DCEP-G vs observation

Arm 2

DPP/DCEP-G alternation regimen

Group Type ACTIVE_COMPARATOR

Maintenance therapy post-HSCT

Intervention Type DRUG

Rituximab vs DPP/DCEP-G vs observation

Arm 3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Maintenance therapy post-HSCT

Rituximab vs DPP/DCEP-G vs observation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ting YANG

Prof.M.D.Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ting Yang, Prof.

Role: primary

+86-591-83357896 ext. 8041

Jianda Hu, Prof.

Role: backup

+86-591-83357896 ext. 8041

Other Identifiers

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Lym-SCT-001

Identifier Type: -

Identifier Source: org_study_id

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