Clinical trial NCT00636909: Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders
Official title: Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-03-17
Enrollment: 25
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: durable engraftment
timeFrame: 100 days
measure: hematopoeitic reconstitution
timeFrame: 3 years
measure: evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
timeFrame: 3 years
Secondary outcomes:
measure: disease free survival and overall survival
timeFrame: 3 years
measure: incidence of treatment related toxicity and acute and chronic graft versus host disease
timeFrame: 100 days
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David F McDermott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: David E Avigan, MD
role: STUDY_DIRECTOR
References: