Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders (MINI HEME)
Primary Purpose
AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cyclophosphamide
fludarabine
cyclosporine
methotrexate
G-CSF
Sponsored by
About this trial
This is an interventional treatment trial for AML focused on measuring 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
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Study treatment arm with G-CSF
Outcomes
Primary Outcome Measures
durable engraftment
hematopoeitic reconstitution
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
Secondary Outcome Measures
disease free survival and overall survival
incidence of treatment related toxicity and acute and chronic graft versus host disease
Full Information
NCT ID
NCT00636909
First Posted
March 10, 2008
Last Updated
April 5, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT00636909
Brief Title
Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders
Acronym
MINI HEME
Official Title
Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Study treatment arm with G-CSF
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
preparative cytoreduction
Intervention Type
Drug
Intervention Name(s)
fludarabine
Intervention Description
preparative cytoreduction
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Description
immunosuppressive therapy
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
immunosuppressive therapy
Intervention Type
Biological
Intervention Name(s)
G-CSF
Intervention Description
foster engraftment
Primary Outcome Measure Information:
Title
durable engraftment
Time Frame
100 days
Title
hematopoeitic reconstitution
Time Frame
3 years
Title
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
Time Frame
3 years
Secondary Outcome Measure Information:
Title
disease free survival and overall survival
Time Frame
3 years
Title
incidence of treatment related toxicity and acute and chronic graft versus host disease
Time Frame
100 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F McDermott, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David E Avigan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders
We'll reach out to this number within 24 hrs