Clinical Drug Experience Knowledgebase

Criteria

Diagnosis of one of the following hematological malignancies:

CML, with 1 of the following:

In first CP AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission at 3 months or a major cytogenetic response (i.e., Ph+ cells < 35%) at 6 months or demonstrated clonal evolution or disease progression during therapy
In accelerated phase with < 15% blasts
In blast crisis that has entered into a second CP following induction chemotherapy

AML, with 1 of the following:

In second or subsequent complete remission (CR) (i.e., < 5% blasts by morphology, no residual leukemia by flow cytometry, and absence of cytogenetic abnormalities)
Failed primary induction chemotherapy, but subsequently entered into a CR with ≤ 2 subsequent re-induction chemotherapy treatment(s)
In first CR with intermediate-risk or poor-risk cytogenetics

ALL with 1 of the following:

In second or subsequent CR
In first CR AND presence of t(9;22)

MDS, with the following:

High-risk disease, defined by IPSS score of ≥ 1.5 at diagnosis AND meets 1 of the following criteria:

≤ 10% blasts at diagnosis
In morphologic CR (< 5% blasts) following cytoreductive chemotherapy

CMML, with 1 of the following:

≤ 10% blasts at diagnosis
In morphologic CR (< 5% blasts) following cytoreductive chemotherapy

CLL/PLL with the following:

Rai stage I-IV disease
Failed ≥ 1 prior chemotherapy regimen (including fludarabine phosphate) or ASCT
Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as < 20% bone marrow involvement AND lymph node size < 3 cm in axial diameter
No bulky tumor masses, elevated lactate dehydrogenase (LDH), B symptoms, or progressive disease prior to transplant

Low-grade non-Hodgkin lymphoma (NHL) (i.e., small lymphocytic lymphoma, follicular center lymphoma [grade 1 or 2], marginal zone lymphoma, or B-cell lymphoma), with the following criteria:

Failed ≥ 1 prior chemotherapy regimen or ASCT
Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as < 20% bone marrow involvement AND lymph node size < 3 cm in axial diameter
Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered a prior regimen)
No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant

Mantle cell lymphoma, with the following:

Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
Responsive or stable disease to most recent prior therapy
No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant

Intermediate-grade NHL (i.e., follicular center lymphoma [grade 3] or diffuse large cell lymphoma), meeting the following criteria:

Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant

Hodgkin lymphoma, with the following:

Relapsed after prior ASCT OR after ≥ 2 combination chemotherapy regimens and ineligible for ASCT
Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant

Peripheral T-cell NHL, with the following:

Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant

Myeloproliferative syndrome with poor risk features, meeting 1 of the following criteria:

< 55 years old AND Lille score of 1
Lille score of 2
HgB < 10 g/dL AND abnormal karyotype

High-risk disease, with 1 of the following:

Age 40-72 years
Any age AND deemed to be at significantly increased risk of morbidity and death following a standard, myeloablative unrelated donor stem cell transplant (e.g., received extensive prior therapy, including ASCT)

HLA-matched unrelated donor available, with 1 of the following:

8/8 match at HLA-A, B, C, or DR loci by high-resolution genotyping

Single allelic mismatch at either the HLA-B or HLA-C loci donor by high-resolution molecular typing

No single allelic mismatch at HLA-A or HLA-DR loci
KPS 80-100%
Adapted weighted Charlson Comorbidity Index < 3
Serum creatinine ≤ 2.0 mg/dL
AST or ALT < 3 times upper limit of normal (ULN)
Total bilirubin < 1.5 times ULN
LVEF ≥ 45%
DLCO > 50%
No hypoxia at rest with oxygen saturation < 92% on room air (corrected with bronchodilator therapy)
No other severe pulmonary function abnormalities
No HIV infection
No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate to high risk for developing severe hepatic disease
No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)