Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies

Inclusion Criteria:

Donor criteria:

Donor is 18 to 70 years of age inclusive

If female and of child-bearing age, must be:

non-pregnant,
not breast feeding and
using adequate contraception
Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for transplant
Donor must be willing to provide written informed consent.
Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis

Adequate neurologic function as defined by:

No evidence of a severe central or peripheral neurologic abnormality.
No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication
Must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test.
Must have an ECOG performance status of 0 or 1
Must demonstrate ability to be compliant with study regimen.
Must not have an active infection at the time of study entry
Not have active alcohol or substance abuse within 6 months of study entry
Not currently enrolled in another investigational agent study
Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation

Recipient criteria:

18 to 65 years of age inclusive
Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant
Provide signed informed consent

If female and of child-bearing age, must be:

non-pregnant,
not breast feeding, and
using adequate contraception

Patient must have one of the following diagnoses:

AML in 1st or subsequent remission or in relapse
ALL in 1st or subsequent remission or in relapse
MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring System
CML in accelerated or second chronic phase
NHL or HD in 2nd or greater complete remission, partial remission,or refractory relapse
CLL Rai Stage 2-4, failing at least 2 prior regimens
MM Stage 2-3
Adequate cardiac function with a left ventricular ejection fraction ≥ 40%

Adequate pulmonary function defined as:

No severe or symptomatic restrictive or obstructive lung disease, and
formal pulmonary function testing showing an forced expiratory volume at 1 second (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon monoxide (DLCO) ≥40% of predicted, corrected for hemoglobin
Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis
Adequate neurologic function as defined by no evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain
No evidence of active infection at the time of the transplant preparative regimen or at the time of transplantation
Patient must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test
ECOG performance status of 0 or 1
Must demonstrate ability to be compliant with medical regimen
Not have active alcohol or substance abuse within 6 months of study entry
Not be concurrently enrolled on another study involving an investigational agent
Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient