Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

Inclusion Criteria

• •Age 18 to 70 years of age.
• •ECOG performance status of 0 or 1.
• •PART 1: Donor must be a 5/6 or 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• •PART 2: Donor must be a 5/6 or 6/6 HLA-matched sibling or 3/6 or 4/6 HLA haploidentical donor willing to donate PBSC for transplant. Haploidentical donors will be allowed to participate upon investigator decision and based on the data reached from 5/6 or 6/6 HLA matched transplant done during Part 1 of the study.
• •Adequate organ function defined by:
• •* serum creatinine within normal limits or a minimum creatinine clearance (CrCl) value of ≥ 60 ml/min calculated using the Modification of Diet in Renal Disease (MDRD) Study equation
• •* AST, ALT and total bilirubin ≤ 2x institutional upper limit of normal.
• •Women of childbearing potential and men must agree to use adequate contraception with two different forms, including one barrier method, during participation in the study and for 2 weeks following dosing with BL-8040. Abstinence is acceptable if this is the established and preferred contraception for the subject.
• •Female subjects must have a negative urine or serum pregnancy test within 10 days prior to taking study medication if of childbearing potential or must be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as:
• •-≥ 45 years of age and has not had menses for \> 2 years
• •Amenorrheic for \> 2 years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation
• •Post-hysterectomy, oophorectomy, or tubal ligation.
• •Able and willing to comply with the requirements of the protocol.
• •Able to understand and willing to sign an IRB-approved written informed consent document.
• •Age 18 to 75 years
• •ECOG performance status of 0-2 (inclusive)
• •One of the following diagnoses:
• •* Acute myelogenous leukemia (AML) in 1st or subsequent remission
• •* Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission
• •* Chronic myelogenous leukemia (CML) in chronic or accelerated phase
• •* Non-Hodgkin lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission
• •* Chronic lymphocytic leukemia (CLL)
• •* Multiple myeloma (MM)
• •* Myelodysplastic syndrome (MDS)
• •* Myeloproliferative neoplasm (MPN) excluding primary or secondary myelofibrosis
• •Adequate organ function defined by:
• •* a creatinine clearance (CrCl) value of ≥ 60 ml/min by MDRD study equation
• •* AST, ALT and a total bilirubin ≤ 2x institutional upper limit of normal.
• •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 FEV1 ≥50% of predicted and a DLCO ≥ 40% of predicted, corrected for hemoglobin.
• •Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as:
• •\*≥ 45 years of age and has not had menses for \> 2 years
• •* Amenorrheic for \> 2 years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation
• •* Post-hysterectomy, oophorectomy, or tubal ligation.
• •Able to understand and willing to sign an IRB-approved written informed consent document.