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


Phase 2
15 Years
65 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related mortality

Safety Issue:

Yes

Principal Investigator

Kyoo H. Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Asan Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000583220

NCT ID:

NCT00627666

Start Date:

January 2003

Completion Date:

June 2010

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • adult acute lymphoblastic leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • untreated adult acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • acute lymphocytic leukemia
  • secondary acute myeloid leukemia
  • acute undifferentiated leukemia
  • mast cell leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Hematologic Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

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