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

Leukemia Clinical Trial

Official title:

The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01828619
• Other study ID #: PKUIH-201303
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 7, 2013
• Last updated: April 9, 2013
• Start date: February 2013

Study information

• Verified date: April 2013
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stem cell engraftment		30day post transplantation	No
Secondary	toxicity and treatment related mortality		100day and 1 year post transplantation	No