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T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia - Article


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In Vitro Fertilization

In Vitro Fertilization (IVF); IVF


Clinical Trial: T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia

This study has been completed.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.

Condition Treatment or Intervention Phase
acute leukemia
atypical chronic myeloid leukemia
childhood lymphoblastic lymphoma
chronic leukemia
myelodysplastic and myeloproliferative disease
Non-Hodgkin's Lymphoma
 Drug: anti-thymocyte globulin
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: filgrastim
 Drug: methylprednisolone
 Drug: thiotepa
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: in vitro-treated bone marrow transplantation
 Procedure: in vitro-treated peripheral blood stem cell transplantation
 Procedure: radiation therapy
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapy;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of T-Cell-Depleted Bone Marrow and Filgrastim (G-CSF)-Stimulated, CD34+, E-Rosette and T-Cell-Depleted Peripheral Blood Stem Cell Transplantation from HLA-Haplotype, Partially Matched Related Donors in Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Severe Aplastic Anemia

Further Study Details: 

OBJECTIVES:

  • Determine the potential of T-cell-depleted bone marrow and peripheral blood stem cells (PBSC) from HLA-haplotype, partially matched related donors to induce extended disease-free survival in patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or severe aplastic anemia who would otherwise be ineligible for transplantation because of the lack of an HLA-identical related or unrelated donor.
  • Determine the impact of filgrastim (G-CSF)-stimulated, CD34+, E-rosette and T-cell-depleted PBSC derived from an HLA-haplotype, partially matched donor on the incidence and quality of engraftment, kinetics, and quality of hematopoietic and immunologic reconstitution, and incidence and severity of graft-versus-host disease (GVHD) in these patients.
  • Correlate the doses of PBSC and clonable T-cells with the incidence of engraftment, extent of chimerism, incidence and severity of acute and chronic GVHD, characteristics of hematopoietic and immunologic reconstitution, and overall and disease-free survival rates at 2-4 years after transplantation in these patients.

OUTLINE: Patients are stratified by number of HLA-incompatible alleles (1 vs 2 or 3).

Patients are followed at 1, 3, 6, and 12 months and then annually for 3 years.

PROJECTED ACCRUAL: A total of 60 patients (30 patients per stratum) will be accrued for this study at a rate of 15 leukemia patients and 5 aplastic anemia patients per year.

Eligibility

Ages Eligible for Study:  up to  49 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:
  • Acute myelogenous leukemia (AML) meeting 1 of the following conditions:
  • Failed to achieve first remission after an intensive induction regimen containing an anthracycline and cytarabine
  • In second remission and not enrolled in a protocol for autologous bone marrow transplantation
  • Failed to achieve or sustain second remission
  • In first remission but at high risk of relapse because of 1 of the following factors:
  • High-risk cytogenetic features (monosomy 7,5q-, trisomy 8, or t(9;22))
  • AML secondary to treatment of a prior malignancy and without good-risk cytogenetic features of t(8;21), t(15;17), or inv 16
  • AML secondary to myelodysplastic disease
  • Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:
  • In second remission with initial relapse occurring within 2 years of diagnosis
  • In first complete remission with high-risk cytogenetics (t(9;22) or t(4;11))
  • In third or subsequent remission
  • Failed to achieve or sustain a second remission
  • Chronic myelogenous leukemia (CML) in first or second chronic phase or accelerated phase
  • Stage IV lymphoblastic lymphoma not in first remission or that failed to achieve a remission within the first 4 weeks of induction therapy
  • Juvenile CML
  • Myelodysplastic syndrome
  • Severe aplastic anemia unresponsive to anti-thymocyte globulin or cyclosporine
  • No CNS or skin involvement with leukemia
  • No requirement for mediastinal irradiation
  • No healthy, HLA-identical related donor of at least 1 year of age or matched unrelated donor available within 4-6 months
  • Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor
  • Willing and able to undergo general anesthesia for marrow donation and a 5-day course of filgrastim (G-CSF) with 2 daily leukaphereses

PATIENT CHARACTERISTICS: Age:

  • Under 50 (50 and over allowed on a case-by-case basis)

Performance status:

  • Age 16 and over:
  • Karnofsky 70-100%
  • Under age 16:
  • Lansky 50-100%

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 2.0 mg/dL (in the absence of liver involvement)
  • AST less than twice normal (in the absence of liver involvement)

Renal:

  • Creatinine normal OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • Asymptomatic or LVEF greater than 50% at rest, with improvement during exercise

Pulmonary:

  • Asymptomatic or DLCO greater than 50% predicted (corrected for hemoglobin)

Other:

  • No known hypersensitivity to mouse protein or chicken egg products
  • No active viral, bacterial, or fungal infection
  • HIV-1, HIV-2, HTLV-1, and HTLV-2 negative
  • No other concurrent medical condition that would preclude transplantation
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Richard J. O'Reilly, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

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

Study ID Numbers:  CDR0000064557; MSKCC-95084; NCI-V96-0809
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002718
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: October 3, 2005
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