| Eligibility |
Inclusion Criteria:
- Patients with one of the high risk myeloid diseases as outlined below. Patients must
have = 5% blasts on the last BM evaluation prior to starting the conditioning regimen.
Diseases included on this protocol include:
1. Acute Myeloid Leukemia (AML) in CR1 with intermediate or high risk features as
defined below:
°Cytogenetic abnormalities which are not considered "good risk" cytogenetic
features (i.e t(8:21), t(15:17), inv 16 without c-kit mutations.
And/or
- Therapy related AML with history of antineoplastic therapy (radiation and/or
chemotherapy) And/or
- Normal karyotype with mutations of FLT3, RUNX1, TP53 mutation, ASXL1 or any
others that are considered to be high risk
2. AML in = 2nd remission
3. Myelodysplastic syndrome, myeloproliferative neoplasms, or MDS/MPN overlap
syndrome with:
°International prognostic scoring system risk score INT-2 or high risk at the
time of transplant evaluation.
And/or
- Any risk category if life-threatening cytopenia exists And/or
- Karyotype or genomic changes that indicate high risk for progression to
acute myelogenous leukemia, including abnormalities of chromosome 7 or 3,
mutations of TP53, or complex or monosomal karyotype.
4. Chronic myelomonocytic leukemia (CMML)
5. Chronic myeloid leukemia (CML) with the following features:
°Patients who have failed or are intolerant to BCR-ABL tyrosine kinase
inhibitors.
And/or
°CML with BCR-ABL mutation consistent with poor response to tyrosine kinase
inhibition (e.g T351l mutation)
6. Patients with severe aplastic anemia
- Chronic lymphocytic leukemia (CLL) with high risk disease as defined by the EBMT
consensus criteria.
- Non-Hodgkin lymphoma meeting both of the following criteria:
- Responding to therapy prior to enrollment.
- Relapse after prior autologous bone marrow transplant or are ineligible for
autologous bone marrow transplant.
- Multiple Myeloma with disease in the following categories:
- Patients with relapsed multiple myeloma following autologous stem cell
transplantation who have achieved at least partial response following additional
chemotherapy
- Patients with high risk cytogenetics at diagnosis must have achieved at least a
partial response following autologous stem cell transplantation. Patients must
have complex karyotype, del17p, t4;14, and/or t14;16 by FISH and/or del13 by
karyotyping.
- Each patient must be willing to participate as a research participant and must sign an
informed consent form.
- Organ Function and Performance Status Criteria:
1. Patients be = 18 years old.
2. Patients must have a Karnofsky (adult) or Performance Status = 70%.
3. Patients must have adequate organ function measured by:
- Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be = 40% and
must improve with exercise.
- Hepatic: < 5x ULN ALT and < 2x ULN total serum bilirubin, unless there is
congenital benign hyperbilirubinemia.
- Renal: CrCl >30ml/min (measured or calculated/estimated).
- Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted
(corrected for hemoglobin)
Exclusion Criteria:
- Prior allogenic hematopoietic stem cell transplantation
- Prior radiation therapy with 400cGY or more of TBI
- BM with increased fibrosis (Reticulin stain > 1/3)
- Active and uncontrolled infection at time of transplantation
- HIV infection
- Seropositivity for HTLV-1
- Inadequate performance status/ organ function
- Pregnancy or breast feeding
- Patient or guardian unable to give informed consent or unable to comply with the
treatment protocol including appropriate supportive care, follow-up, and research
tests.
Donor Inclusion and Exclusion Criteria:
- Must be a 10/10 HLA genotypically match related or unrelated donor at all A, B, C,
DRB1, and DQB1 loci, as tested by DNA analysis
- Able to provide informed consent for the donation process per institutional standards
- Meet standard criteria for donor collection as defined by the National Marrow Donor
Program Guidelines
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