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Completed

NCT Number: NCT00636909

Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

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.

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Key information

Conditions

AML ALL Anemia Anemia, Aplastic Aplastic Anemia Blast Crisis Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders CLL CML Chronic Phase, Accelerated Phase, or Blast Crisis Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Lymphatic Diseases Lymphoma Lymphoproliferative Disorders MDS MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET) Multiple Myeloma Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA Vascular Diseases

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclophosphamide

Drug

preparative cytoreduction

Fludarabine

Drug

preparative cytoreduction

cyclosporine

Drug

immunosuppressive therapy

methotrexate

Drug

immunosuppressive therapy

G-CSF

Biological

foster engraftment

Primary outcomes

  1. durable engraftment

    Time frame: 100 days

  2. hematopoeitic reconstitution

    Time frame: 3 years

  3. evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells

    Time frame: 3 years

Secondary outcomes

  1. disease free survival and overall survival

    Time frame: 3 years

  2. incidence of treatment related toxicity and acute and chronic graft versus host disease

    Time frame: 100 days

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Amgen

Registry information

Official study title

Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Acronym: MINI HEME

Important dates

Study start
1999
Primary completion
2006
First posted
Mar 17, 2008
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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