ALL, AML, APLASTIC ANEMIA, CLL, CML Chronic Phase, Accelerated Phase, or Blast Crisis, MDS, MULTIPLE MYELOMA, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET), RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA
Conditions
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
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.
Interventions
DRUGCyclophosphamide
preparative cytoreduction
DRUGfludarabine
preparative cytoreduction
DRUGcyclosporine
immunosuppressive therapy
DRUGmethotrexate
immunosuppressive therapy
BIOLOGICALG-CSF
foster engraftment
Sponsors
Amgen
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| durable engraftment | 100 days |
| hematopoeitic reconstitution | 3 years |
| evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival and overall survival | 3 years |
| incidence of treatment related toxicity and acute and chronic graft versus host disease | 100 days |
Outcome results
None listed