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Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders (MINI HEME)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Beth Israel Deaconess Medical Center
Amgen
Information provided by: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00636909
  Purpose

The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.


Condition Intervention Phase
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)
Drug: Cyclophosphamide
Drug: fludarabine
Drug: cyclosporine
Drug: methotrexate
Biological: G-CSF
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Anemia Cancer Hodgkin's Disease Lymphoma Multiple Myeloma
Drug Information available for: Cyclophosphamide Methotrexate Fludarabine Fludarabine monophosphate Cyclosporin Cyclosporine Granulocyte colony-stimulating factor
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • durable engraftment [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • hematopoeitic reconstitution [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease free survival and overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • incidence of treatment related toxicity and acute and chronic graft versus host disease [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: July 1999
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Study treatment arm with G-CSF
Drug: Cyclophosphamide
preparative cytoreduction
Drug: fludarabine
preparative cytoreduction
Drug: cyclosporine
immunosuppressive therapy
Drug: methotrexate
immunosuppressive therapy
Biological: G-CSF
foster engraftment

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636909

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Amgen
Investigators
Principal Investigator: David F McDermott, MD Beth Israel Deaconess Medical Center
Study Director: David E Avigan, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: BIDMC ( David F. McDermott, MD )
Study ID Numbers: 2001P002293, W-99-0234-FB
Study First Received: March 10, 2008
Last Updated: March 10, 2008
ClinicalTrials.gov Identifier: NCT00636909  
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
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

Study placed in the following topic categories:
Blast Crisis
Cyclosporine
Hodgkin's disease
Clotrimazole
Blood Protein Disorders
Miconazole
Hodgkin lymphoma, adult
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Cyclosporins
Leukemia
Hemorrhagic Disorders
Multiple myeloma
Anemia, Aplastic
Methotrexate
Hodgkin Disease
Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Tioconazole
Anemia
Myeloproliferative Disorders
Vascular Diseases
Fludarabine monophosphate
Leukemia, Myeloid
Multiple Myeloma
Folic Acid
Lymphatic Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Neoplastic Processes
Pathologic Processes
Therapeutic Uses
Antifungal Agents
Abortifacient Agents
Cardiovascular Diseases
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Disease
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on January 16, 2009