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
Recruitment status was Active, not recruiting
Sponsor:
Beth Israel Deaconess Medical Center
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
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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:
MedlinePlus related topics:
Anemia
Aplastic Anemia
Blood Disorders
Cancer
Hodgkin Disease
Lymphoma
Multiple Myeloma
Drug Information available for:
Cyclophosphamide
Methotrexate
Methotrexate sodium
Fludarabine
Cyclosporine
Fludarabine phosphate
Granulocyte colony-stimulating factor
U.S. FDA Resources
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
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 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 Cyclosporins |
ClinicalTrials.gov processed this record on June 13, 2013