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Stem Cell Mobilizer
MGTA-145 for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Research Sponsored by Ensoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21, 28, 56, 100, 180, and 365
Awards & highlights
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.
Eligible Conditions
- Peripheral Blood Stem Cell Donation
- Healthy Donors
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myelodysplastic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 21, 28, 56, 100, 180, and 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21, 28, 56, 100, 180, and 365
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Adverse Events Experienced by Donors
Adverse Events Related to Allograft
Graft Durability
+7 moreSide effects data
From 2022 Phase 2 trial • 25 Patients • NCT0455274352%
Pain
28%
Paresthesia
24%
Nausea
20%
Platelet count decreased
20%
Hypocalcemia
12%
Anemia
12%
Hypokalemia
8%
Vomiting
8%
Headache
8%
Oral dysesthesia
4%
Other - Poor Graft Function (anemia, neutropenia, thrombocytopenia)
4%
Diarrhea
4%
Constipation
4%
Aspartate aminotransferase increased
4%
Alanine aminotransferase increased
4%
Dizziness
4%
Hot flashes
4%
Insomnia
4%
Urinary frequency
4%
Hyperhidrosis
4%
Fatigue
4%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
MGTA-145 and Plerixafor HSC Mobilization
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single dose MGTA-145 plus plerixafor followed by apheresisExperimental Treatment2 Interventions
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~710
MGTA-145
2019
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
EnsomaLead Sponsor
3 Previous Clinical Trials
131 Total Patients Enrolled
Magenta Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
164 Total Patients Enrolled
National Marrow Donor ProgramOTHER
60 Previous Clinical Trials
202,553 Total Patients Enrolled
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