Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Conditions
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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)

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: fludarabine
* Drug: cyclosporine
* Drug: methotrexate
* Biological: G-CSF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Study treatment arm with G-CSF | Drug: Cyclophosphamide<br>* preparative cytoreduction<br>Drug: fludarabine<br>* preparative cytoreduction<br>Drug: cyclosporine<br>* immunosuppressive therapy<br>Drug: methotrexate<br>* immunosuppressive therapy<br>Biological: G-CSF<br>* foster engraftment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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