MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malign… (NCT04762875) | Clinical Trial Compass
TerminatedPhase 2
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
Stopped: This study was voluntarily terminated due to a business decision not to proceed and not due to any safety issue
United States7 participantsStarted 2021-06-16
Plain-language summary
This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Donor Inclusion Criteria:
* Donor medical suitability and eligibility will be determined following Institution or NMDP/Be The Match standards
* Age 18-65 years old at the time of signing informed consent
* 8/8 (HLA- A, B, C, and DRB1) HLA-matched sibling or volunteer unrelated donor
* Fulfill Institution or NMDP/Be The Match criteria to serve as a mobilized blood cell donor
* Serum creatinine \< 1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CRCL) \> 50 mL/min using the Modification of Diet in Renal Disease Study (MDRD) equation or similar method
Recipient Inclusion Criteria:
* At least 18 years old at the time of signing informed consent
* Has an available 8/8 (HLA- A, B, C, and DRB1) HLA-matched sibling or volunteer unrelated donor willing to donate peripheral blood stem cells (PBSC) for transplant
* Fulfill additional individual Transplant Center Criteria for transplant beyond NMDP/Be The Match criteria
* One of the following diagnoses:
* Acute myelogenous leukemia (AML) in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts. Documentation of bone marrow assessment will be accepted within 45 days prior to the date of consent.
* Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts. Documentation of bone marrow assessment will be accepted within 45 days prior to the date of consent.
* Patients with myelodysplasia (MDS) with no circ…