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

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01828619
• Collaborator: (none)
• Enrollment: 60
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Myelodysplastic Syndrome	Procedure: modified BuFlu conditioning

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

1. stem cell engraftment [30day post transplantation]

Secondary Outcome Measures

1. toxicity and treatment related mortality [100day and 1 year post transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China	100044

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

• Principal Investigator: XiaoJun Huang, MD, Peking University People's Hospital, Department of Hematology

Study Documents (Full-Text)

None provided.

More Information

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. Epub 2006 Jul 27. Review.
• 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. Epub 2004 Apr 8.

• Responsible Party: FENGRONG WANG, Department of Hematology, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT01828619
• Other Study ID Numbers: PKUIH-201303
• First Posted: Apr 10, 2013
• Last Update Posted: Apr 10, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by FENGRONG WANG, Department of Hematology, Peking University People's Hospital: Hematopoietic Stem Cell Transplantation; Busulfan; Fludarabine
• Additional relevant MeSH terms: Myelodysplastic Syndromes

Study Results

No Results Posted as of Apr 10, 2013