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NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING


N/A
N/A
65 Years
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Nonmalignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING


OBJECTIVES:

- Determine the safety and efficacy of non-T-cell depleted, HLA-haploidentical related
donor hematopoietic stem cell transplantation after a reduced-intensity conditioning
regimen comprising busulfan, fludarabine phosphate, anti-thymocyte globulin, and
methylprednisolone in patients with hematologic cancer, recurrent or metastatic solid
tumors, or other diseases.

OUTLINE:

- Reduced-intensity conditioning regimen: Patients receive busulfan IV 4 times daily on
days -7 and -6; fludarabine phosphate IV over 30 minutes on days -7 to -2; and
methylprednisolone IV over 30 minutes followed by anti-thymocyte globulin IV over 4
hours on days -4 to -1.

- Donor hematopoietic stem cell transplantation: Patients receive donor peripheral blood
stem cells IV over 1 hour on days 0 and 1.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4
hours or orally twice daily beginning on day -1 and continuing until day 60, followed
by a taper in the absence of GVHD. Patients also receive methotrexate IV on days 2, 4,
7, and 12.

After the transplant, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- High-risk acute leukemia, including any of the following:

- Refractory acute leukemia

- Acute leukemia beyond first remission

- Acute leukemia in first remission with poor prognostic features (e.g.,
chromosomal changes suggesting poor prognosis)

- Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase

- Severe aplastic anemia that is not responsive to immunosuppressive therapy

- Myelodysplastic syndromes, including any of the following:

- Refractory anemia (RA) or RA with ringed sideroblasts with severe cytopenia

- RA with excess blasts (RAEB)

- RAEB in transformation

- Chronic myelomonocytic leukemia

- Refractory or relapsed non-Hodgkin or Hodgkin lymphoma

- Multiple myeloma

- Biopsy proven measurable solid tumor meeting 1 of the following criteria:

- Recurrent disease after primary treatment and deemed incurable to standard
treatment

- Metastatic disease for which no known standard therapy that is potentially
curative or definitely capable of extending life expectancy exists

- Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Bilirubin < 2.0 mg/dL

- AST < 3 times upper limit of normal

- Creatinine < 2.0 mg/dL

- Ejection fraction > 40% by MUGA

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Engraftment (neutrophil, platelet, and red blood cells)

Safety Issue:

No

Principal Investigator

Kyoo H. Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Asan Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000561542

NCT ID:

NCT00521430

Start Date:

April 2004

Completion Date:

September 2008

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Nonmalignant Neoplasm
  • Unspecified Adult Solid Tumor, Protocol Specific
  • recurrent childhood grade III lymphomatoid granulomatosis
  • childhood diffuse large cell lymphoma
  • recurrent childhood large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • childhood nasal type extranodal NK/T-cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • aplastic anemia
  • recurrent childhood acute lymphoblastic leukemia
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • 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)
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • refractory anemia with ringed sideroblasts
  • refractory anemia
  • refractory multiple myeloma
  • chronic myelomonocytic leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • adult nasal type extranodal NK/T-cell lymphoma
  • Waldenström macroglobulinemia
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • cutaneous B-cell non-Hodgkin lymphoma
  • unspecified adult solid tumor, protocol specific
  • childhood chronic myelogenous leukemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • secondary myelodysplastic syndromes
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic

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