Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

NCT ID: NCT02306837

Last Updated: 2016-09-08

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

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-09-30

Brief Summary

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To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

Detailed Description

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Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

Conditions

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Effects of Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Consolidation chemo

Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen

Group Type EXPERIMENTAL

Bu-CY-E

Intervention Type DRUG

mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT

Interventions

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Bu-CY-E

mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT

Intervention Type DRUG

Other Intervention Names

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mini Bu-Cy-E

Eligibility Criteria

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Inclusion Criteria

* Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
* ECOG: 0-2
* Tbil \< 1.5x ULN and AST/ALT \<2.5x ULN
* With informed consent

Exclusion Criteria

* Life expectancy \< 3 months
* Women in pregnancy
* uncontrollable infection disease
* serum Cr \>400mmol/l
* uncontroled diabetis and heart disease
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Head, Blood & Marrow Transplantation Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiong Hu, M.D,

Role: PRINCIPAL_INVESTIGATOR

Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine

Locations

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Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Shanghai No 10 Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiong Hu, M.D,

Role: CONTACT

86-21-64370045 ext. 601878

Facility Contacts

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Jiong HU, M.D.

Role: primary

0086-64370045 ext. 601818

JunMei Shi, M.D, Ph.D,

Role: primary

Other Identifiers

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Lym-Auto-RJH-2014

Identifier Type: -

Identifier Source: org_study_id

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