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The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation


Phase 2
N/A
65 Years
Open (Enrolling)
Both
Adult Langerhans Cell Histiocytosis, Childhood Langerhans Cell Histiocytosis, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation


OBJECTIVES:

- Determine the efficacy and safety of allogeneic peripheral blood stem cell
transplantation in achieving engraftment in patients with hematologic malignancy.

- Determine the hematopoietic recovery, incidence of chemoradiotherapeutic toxicity,
relapse, graft-versus-host disease, and survival of patients treated with this regimen.

OUTLINE: Patients receive a preparative chemoradiotherapeutic regimen and graft-versus-host
disease prophylaxis prior to transplantation. Patients undergo allogeneic peripheral blood
stem cell transplantation on day 0.

Patients are followed every 1-2 weeks for 6 months and at 9, 12, 24, and 36 months.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of one of the following:

- Chronic myelogenous leukemia

- Philadelphia chromosome-positive OR

- Molecular evidence of bcr/abl gene rearrangement

- Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses,
myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia,
paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia

- Confirmed by cytochemistry, immunophenotyping, and/or chromosomal
abnormalities

- Multiple myeloma

- Hereditary immunodeficiency disorders

- Confirmed by immunologic determination

- Sickle cell anemia or beta-thalassemia

- Confirmed by hemoglobin electrophoresis

- Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic
leukodystrophy)

- Confirmed by metabolic testing

- Other non-malignant conditions

- Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

- 65 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

David G. Savage, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000068388

NCT ID:

NCT00008216

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Adult Langerhans Cell Histiocytosis
  • Childhood Langerhans Cell Histiocytosis
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • stage IV adult Hodgkin lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • childhood Langerhans cell histiocytosis
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Philadelphia chromosome negative chronic myelogenous leukemia
  • stage IV childhood Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • intraocular lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • juvenile myelomonocytic leukemia
  • childhood chronic myelogenous leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • chronic myelomonocytic leukemia
  • contiguous stage II small lymphocytic lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • childhood myelodysplastic syndromes
  • adult Langerhans cell histiocytosis
  • Neoplasms
  • Histiocytosis
  • Histiocytosis, Langerhans-Cell
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032