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Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders


Phase 2
N/A
65 Years
Open (Enrolling)
Both
AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)

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Trial Information

Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Inclusion Criteria


Inclusion Criteria - Patient:

- AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED
NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma,
MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET

- Age less than 65 years

- Patients must have a healthy family member who is HLA-identical to the recipient or
has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo
2-4 daily leukaphereses

- Each patient must sign an informed consent and be willing to participate as a
research subject after having been advised of the nature and risk of the study prior
to entering protocol

Inclusion Criteria - Donor:

- Absence of hematologic or marrow function related diseases that interferes with the
collection of sufficient numbers of normal progenitor cells

- Absence of any medical condition that would pose a serious health risk by undergoing
peripheral blood stem cell harvest

- Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C

- The donor must be blood relation. A prospective related donor must be at least
genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.

Exclusion Criteria - Patient:

- Active CNS involvement

- Females who are pregnant or breast feeding

- ECOG performance status > 1. Karnofsky performance status < 80%

- LVEF < 40%

- Active viral, bacterial, or fungal infection

- Patients seropositive for HIV; HTLV -1

- Patients not providing informed consent

- Patients with known hypersensitivity to E. Coli derived product

Exclusion Criteria - Donor:

- A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral
hepatitis infection. Presence of any medical condition that would pose a serious
health risk by undergoing peripheral blood stem cell harvest. Donors with known
hypersensitivity to E. Coli derived products.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

durable engraftment

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

David F McDermott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

2001P002293

NCT ID:

NCT00636909

Start Date:

July 1999

Completion Date:

Related Keywords:

  • AML
  • ALL
  • CML Chronic Phase, Accelerated Phase, or Blast Crisis
  • CLL
  • MDS
  • RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA
  • Aplastic Anemia
  • Multiple Myeloma
  • MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
  • AML
  • ALL
  • CML
  • CLL
  • MDS
  • NHL
  • HODGKIN'S LYMPHOMA
  • APLASTIC ANEMIA
  • MULTIPLE MYELOMA
  • MYELOPROLIFERATIVE DISORDER
  • ALLOGENEIC
  • STEM CELL TRANSPLANT
  • HEMATOLOGIC DISORDERS
  • CYCLOPHOSPHAMIDE
  • FLUDARABINE
  • CYCLOSPORINE
  • METHOTREXATE
  • G-CSF
  • GVHD
  • ENGRAFTMENT
  • CHIMERISM
  • Anemia
  • Anemia, Aplastic
  • Blast Crisis
  • Hematologic Diseases
  • Hodgkin Disease
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myeloproliferative Disorders

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