BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT

NCT ID: NCT03229616

Last Updated: 2017-10-12

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2020-06-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed Description

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Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.

Conditions

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Autologous Hematopoietic Stem Cell Transplantation Diffuse Large B-cell Lymphoma Conditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BUCY+VP-16

For DLBCL patients undergoing auto-HSCT,BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/day on days -3 and -2.

Group Type EXPERIMENTAL

Busulfan (BU)

Intervention Type DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Cyclophosphamide (CY)

Intervention Type DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Etoposide (VP-16)

Intervention Type DRUG

Etoposide was administered at 15 mg/kg/day on days -3 to -2.

BUCY

For DLBCL patients undergoing auto-HSCT,BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days -3 and -2.

Group Type ACTIVE_COMPARATOR

Busulfan (BU)

Intervention Type DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Cyclophosphamide (CY)

Intervention Type DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Interventions

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Busulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Intervention Type DRUG

Cyclophosphamide (CY)

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Intervention Type DRUG

Etoposide (VP-16)

Etoposide was administered at 15 mg/kg/day on days -3 to -2.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diffuse large B-cell lymphoma patients
* Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting of peripheral blood stem cells and receiving one cycle of chemotherapy

Exclusion Criteria

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifa Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifa Liu

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qifa Liu

Role: CONTACT

Phone: +862061641611

Email: [email protected]

Facility Contacts

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Li Xuan

Role: primary

Other Identifiers

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BUCY+VP-16 vs BUCY-DLBCL-2017

Identifier Type: -

Identifier Source: org_study_id