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Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematological Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Intervention: anti-thymocyte globulin (Biological); busulfan (Drug); fludarabine phosphate (Drug); leucovorin calcium (Drug); methotrexate (Drug); allogeneic bone marrow transplantation (Procedure); allogeneic hematopoietic stem cell transplantation (Procedure); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Kyoo H. Lee, MD, Study Chair, Affiliation: Asan Medical Center


RATIONALE: Giving chemotherapy before a donor bone marrow stem cell transplant helps stop the growth of cancer cells. Chemotherapy and antithymocyte globulin stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving donor stem cell transplant together with busulfan, fludarabine, and antithymocyte globulin works in treating patients with hematological cancer.

Clinical Details

Official title: Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning For Patients With Hematological Malignancies

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Treatment-related mortality


Secondary outcome:

Regimen-related toxicities



Overall survival

Failure-free survival

100-day transplant-related mortality

Detailed description: OBJECTIVES:

- To investigate whether unrelated donor hematopoietic stem cell transplantation using a

nonmyeloablative conditioning regimen comprising busulfan, fludarabine phosphate, and anti-thymocyte globulin can reduce treatment-related mortality in patients with hematologic malignancies.

- To investigate whether this regimen can be sufficiently immunosuppressive to enable

engraftment of HLA-matched unrelated hematopoietic stem cells. OUTLINE: This is a multicenter study. Prior to receiving the conditioning chemotherapy regimen, all patients with acute leukemia, chronic myelogenous leukemia (CML), and high-risk myelodysplastic syndromes (chronic myelomonocytic leukemia, atypical CML, and refractory anemia with excess blasts) receive one dose of intrathecal (IT) methotrexate. These patients also receive leucovorin calcium IV or orally 4 hours after IT methotrexate and every 6 hours for a total of 8 doses.

- Nonmyeloablative conditioning regimen: Patients receive fludarabine phosphate IV over

30 minutes on days - 7 to -2, busulfan IV over 3 hours on days -7 to -6, anti-thymocyte

globulin IV over 4 hours on days - 4 to -2.

- Allogeneic bone marrow stem cell transplantation (SCT): Patients undergo allogeneic

bone marrow SCT on day 0.

- Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine (CSA) IV

over 2-4 hours every 12 hours starting on day - 1 and continuing until day 180 (CSA can

be given orally every 12 hours once oral medication can be tolerated) and methotrexate IV on days 1, 3 , 6 , and 11. Once blood counts recover, patients with acute leukemia or CML in blast crisis resume IT methotrexate once every 2 weeks for a total of 3 doses. Patients also receive leucovorin calcium IV or orally 4 hours after IT methotrexate and then every 6 hours for a total of 8 doses. Patients are followed for at least 10 years after SCT.


Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.



- Diagnosis of any 1 of the following:

- Acute leukemia

- Chronic myelogenous leukemia

- Myelodysplastic syndromes

- Must have an unrelated donor available who is matched for HLA-A and -B by serology

and for DRB1 by molecular typing PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Bilirubin < 3. 0 mg/dL

- Creatinine < 2. 0 mg/dL

- AST and ALT < 3 times the upper limit of normal

- Not pregnant or nursing

- Ejection fraction ≥ 45% by MUGA scan or ECHO

- No major illness or organ failure

- No severe psychiatric disorder or mental deficiency that makes compliance with the

treatment unlikely and informed consent impossible PRIOR CONCURRENT THERAPY:

- Not specified

Locations and Contacts

Asan Medical Center - University of Ulsan College of Medicine, Seoul 138-736, Korea, Republic of
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2003
Last updated: March 25, 2013

Page last updated: August 20, 2015

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