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Status unknownNCT01828619Updated Apr 10, 2013

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

An observational study in Leukemia and Myelodysplastic Syndrome, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-10.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
55 Years to 70 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Leukemia
  • Myelodysplastic Syndrome

Keywords

  • Hematopoietic Stem Cell Transplantation
  • Busulfan
  • Fludarabine
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In context

Myelodysplastic Syndromes

2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.

This study's planned enrollment of 60 is below the median of 146 across 215 observational studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population is patients with hematologic malignant diseases, who will undergo HLA matched HSCT.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • KPS status \<70
  • cardiac EF\<50%
  • creatine clearance \<50 ml/min
  • ALT more than 10 times of upper normal limit
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: modified BuFlu conditioning

Interventions

  • Proceduremodified 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.

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What researchers measure

Primary outcomes

  1. stem cell engraftment

    Time frame: 30day post transplantation

Secondary outcomes

  1. toxicity and treatment related mortality

    Time frame: 100day and 1 year post transplantation

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Study locations

1 site
  • Peking University People's Hospital
    Beijing, 100044, China
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References and documents

Publications

  • 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. PubMed 16871277 ↗
  • 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. PubMed 15073038 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01828619
Lead sponsor
Peking University People's Hospital
Responsible party
FENGRONG WANG (Department of Hematology, Peking University People's Hospital) — Principal investigator
First posted
Apr 10, 2013
Start date
Feb 2013
Primary completion
Dec 2015 (estimated)
Last update
Apr 10, 2013

Study contacts

XiaoJun Huang, MD
principal investigator · Peking University People's Hospital, Department of Hematology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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