Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders (MINI HEME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Amgen
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00636909
First received: March 10, 2008
Last updated: October 16, 2009
Last verified: September 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Resource links provided by NLM:


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
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: David F. McDermott, MD, BIDMC
ClinicalTrials.gov Identifier: NCT00636909     History of Changes
Other Study ID Numbers: 2001P002293, W-99-0234-FB
Study First Received: March 10, 2008
Last Updated: October 16, 2009
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

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Blast Crisis
Hematologic Diseases
Hodgkin Disease
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Cyclophosphamide

ClinicalTrials.gov processed this record on August 21, 2014