Status:
TERMINATED
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
Lead Sponsor:
Ensoma
Collaborating Sponsors:
National Marrow Donor Program
Conditions:
Related Donors Donating PBSC to a Family Member
Healthy Donors
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a Phase II, open-label, multicenter, prospective study of MGTA-145 + plerixafor mobilized HLA-matched sibling and matched unrelated donor allografts for myeloablative hematopoietic stem cell t...
Eligibility Criteria
Inclusion
- Donor
- 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
- 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 circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% or 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the date of consent.
- Cardiac function: Left ventricular ejection fraction at least 45% based on most recent echocardiogram or MUGA results obtained via standard of care
- Estimated creatinine clearance acceptable per local institutional guidelines
- Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin at least 50% and forced expiratory volume in first second (FEV1) predicted at least 50% based on most recent DLCO results obtained via standard of care
- Liver function acceptable per local institutional guidelines
- Karnofsky performance status (KPS) of 70% or greater
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of 4 or less
Exclusion
- Donor
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04762875
Start Date
June 16 2021
End Date
March 14 2022
Last Update
November 6 2024
Active Locations (8)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Stanford Health Care
Stanford, California, United States, 94305
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902