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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight of ≥ 35 Kg
Subjects with Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
Must not have
Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
History of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial aims to test the safety of TRX-103 in patients with blood cancers who are undergoing a stem cell transplant. They plan to enroll up to 36 patients over 18-24 months
Who is the study for?
This trial is for people with various blood cancers like leukemia who are undergoing a stem cell transplant from a donor that doesn't fully match their tissue type. They're testing if TRX-103 can prevent a common and serious complication called Graft-versus-Host Disease.
What is being tested?
The study is looking at the safety of TRX-103 when given once after a mismatched stem cell transplant. It's an early-phase trial, meaning it's one of the first times this drug is being tested in humans to see how well they tolerate it.
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety, specific side effects of TRX-103 aren't listed yet. Generally, such trials monitor for any unexpected reactions ranging from mild symptoms to more severe complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 35 Kg.
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I have been diagnosed with a specific type of blood cancer.
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I am mostly able to care for myself.
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I do not have any ongoing serious infections.
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I have a donor for a stem cell transplant that is not a perfect match.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a bone marrow or stem cell transplant from a donor.
Select...
I have a history of major organ dysfunction or am on treatment for heart issues.
Select...
I have had TTP or HUS and cannot be treated with sirolimus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: TRX-103Experimental Treatment1 Intervention
TRX-103 will be infused on time post hematopoietic stem cell transplant (HSCT).
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Who is running the clinical trial?
Tr1X, Inc.Lead Sponsor
Maria Grazia Roncarolo, MDStudy DirectorTr1X, Inc.
1 Previous Clinical Trials
30 Total Patients Enrolled
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