Clinical trial · Interventional
Study of Busulfan and FLAG Conditioning Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation
Safety and Efficacy Study of Busulfan/FLAG Conditioning Regimen in Patients With Relapsed/Refractory Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
NCT02784561CI-TRIAL-00022401unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem cell transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd) | Drug | Busulfan | ALIAS |
| Cytarabine(Actavis Italy S.p.A) | Drug | Cytarabine | ALIAS |
| Fludarabine (Bayer) | Drug | Fludarabine | ALIAS |
| granulocyte colony-stimulating factor (KirinKunpeng) | Drug | — | UNRESOLVED |
| rabbit ATG（Sanofi/Genzyme） | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Busulfan/FLAG conditioning regimen
- description
- All recipients in this arm received the conditioning regimen consisting of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor). The conditioning regimen for peripheral blood stem cell transplantation consisted of busulfan (3.2 mg/kg/ day intravenously \[i.v.\], days -10 to -8), fludarabine (30 mg/m2, day -7 to -3), cytarabine (1.6 g/m2/day, days -7 to -3), granulocyte colony-stimulating factor (5 ug/ kg, day -8 to -3). ATG (Thymoglobuline, rabbit) for haploidentical and matched unrelated donors transplantation recipients was used on 2.5 mg/kg/d from days -5 to -2).
- interventionNames
- Drug: Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)
- Drug: Cytarabine(Actavis Italy S.p.A)
- Drug: Fludarabine (Bayer)
- Drug: granulocyte colony-stimulating factor (KirinKunpeng)
- Drug: rabbit ATG（Sanofi/Genzyme）
Primary outcomes (1)
- measure
- Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria
- timeFrame
- two years
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * relapsed/refractory acute leukemia regardless of cytogenetics * All patients should aged 12 to 65 years * Have matched sibling donors, ≥8/10 HLA(human leukocyte antigen) matched unrelated donors or haploidentical donors * Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases Exclusion Criteria: * Patients aged less than 12 years old * Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases * Acute myeloid leukemia patients with t (15;17)
References
Publications (8)
- BACKGROUNDForman SJ, Rowe JM. The myth of the second remission of acute leukemia in the adult. Blood. 2013 Feb 14;121(7):1077-82. doi: 10.1182/blood-2012-08-234492. Epub 2012 Dec 14. PMID 23243288
- BACKGROUNDTang W, Fan X, Wang L, Hu J. Busulfan and fludarabine conditioning regimen given at hematological nadir of cytoreduction fludarabine, cytarabine, and idarubicin chemotherapy in patients with refractory acute myeloid leukemia undergoing allogeneic stem cell transplantation: a single arm pilot consort study. Medicine (Baltimore). 2015 Apr;94(15):e706. doi: 10.1097/MD.0000000000000706. PMID 25881847
- BACKGROUNDMiddeke JM, Herbst R, Parmentier S, Bug G, Hanel M, Stuhler G, Schafer-Eckart K, Rosler W, Klein S, Bethge W, Bitz U, Buttner B, Knoth H, Alakel N, Schaich M, Morgner A, Kramer M, Sockel K, von Bonin M, Stolzel F, Platzbecker U, Rollig C, Thiede C, Ehninger G, Bornhauser M, Schetelig J. Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE trial. Leukemia. 2016 Feb;30(2):261-7. doi: 10.1038/leu.2015.226. Epub 2015 Aug 18. PMID 26283567
- BACKGROUNDFu H, Xu L, Liu D, Zhang X, Liu K, Chen H, Wang Y, Han W, Han T, Huang X. Late-onset hemorrhagic cystitis after haploidentical hematopoietic stem cell transplantation in patients with advanced leukemia: differences in ATG dosage are key. Int J Hematol. 2013 Jul;98(1):89-95. doi: 10.1007/s12185-013-1350-8. Epub 2013 Apr 30. PMID 23632950
- BACKGROUNDWang Y, Liu QF, Xu LP, Liu KY, Zhang XH, Ma X, Fan ZP, Wu DP, Huang XJ. Haploidentical vs identical-sibling transplant for AML in remission: a multicenter, prospective study. Blood. 2015 Jun 18;125(25):3956-62. doi: 10.1182/blood-2015-02-627786. Epub 2015 May 4. PMID 25940714
- BACKGROUNDSun Y, Beohou E, Labopin M, Volin L, Milpied N, Yakoub-Agha I, Piemontese S, Polge E, Houhou M, Huang XJ, Mohty M, Nagler A, Gorin NC; Acute Leukemia Working Party of the EBMT. Unmanipulated haploidentical versus matched unrelated donor allogeneic stem cell transplantation in adult patients with acute myelogenous leukemia in first remission: a retrospective pair-matched comparative study of the Beijing approach with the EBMT database. Haematologica. 2016 Aug;101(8):e352-4. doi: 10.3324/haematol.2015.140509. Epub 2016 Apr 14. No abstract available.