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Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling and volunteer unrelated donors. Unfortunately, this process requires four to six days of G-CSF injection and can be associated with side effects, most notably bone pain and rarely splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs on the same day as BL-8040 administration. This study will evaluate the safety and efficacy of this novel agent for hematopoietic progenitor cell mobilization and allogeneic transplantation based on the following hypotheses:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria (DONOR):
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:
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.
Inclusion Criteria (RECIPIENT):
Age 18 to 75 years
ECOG performance status of 0-2 (inclusive)
One of the following diagnoses:
Adequate organ function defined by:
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
Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria (DONOR):
Exclusion Criteria (RECIPIENT):
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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