Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients

NCT ID: NCT01828619

Last Updated: 2013-04-10

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Brief Summary

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The purpose of this study is to determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.

Detailed Description

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Conditions

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Leukemia Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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modified BuFlu, HSCT, elder/intolerable

The study group is the hematlogic malignant patients that older than 55years and/or with severe concurrent medical conditions, who will undergo HLA-matced allogenic HSCT to cure the disease. The patients will received a modified BuFlu conditioning.

modified BuFlu conditioning

Intervention Type PROCEDURE

The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m\^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.

Interventions

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modified BuFlu conditioning

The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m\^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosed of hematologic malignant disease
* will undergo HLA matced HSCT
* age \>=55years
* \<55year and intolerable to standard myeloablative conditioning

Exclusion Criteria

* KPS status \<70
* cardiac EF\<50%
* creatine clearance \<50 ml/min
* ALT more than 10 times of upper normal limit
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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FENGRONG WANG

Department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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XiaoJun Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, Department of Hematology

Locations

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Peking University People's Hospital

Beijing, , China

Site Status

Countries

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China

References

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Barrett AJ, Savani BN. Stem cell transplantation with reduced-intensity conditioning regimens: a review of ten years experience with new transplant concepts and new therapeutic agents. Leukemia. 2006 Oct;20(10):1661-72. doi: 10.1038/sj.leu.2404334. Epub 2006 Jul 27.

Reference Type BACKGROUND
PMID: 16871277 (View on PubMed)

de Lima M, Couriel D, Thall PF, Wang X, Madden T, Jones R, Shpall EJ, Shahjahan M, Pierre B, Giralt S, Korbling M, Russell JA, Champlin RE, Andersson BS. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood. 2004 Aug 1;104(3):857-64. doi: 10.1182/blood-2004-02-0414. Epub 2004 Apr 8.

Reference Type BACKGROUND
PMID: 15073038 (View on PubMed)

Other Identifiers

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PKUIH-201303

Identifier Type: -

Identifier Source: org_study_id

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