Orca-T for Acute Myeloid Leukemia or Myelodysplastic Syndrome
This study is looking at a treatment called Orca-T for adults with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Orca-T is a special type of cell therapy made from a donor's blood that helps your body fight cancer. You might be able to join if you are at least 18 years old and have AML or MDS that is in remission (meaning the cancer is not active). The study aims to see how safe and effective Orca-T is when given after a less intense type of transplant preparation (reduced intensity or non-myeloablative conditioning). Researchers will measure success by looking at how well patients stay free of both graft-versus-host disease (a common transplant complication) and cancer relapse, and how quickly new blood cells grow. This study is currently unclear about its recruitment status and plans to enroll 80 participants.
- Study design
- This is a multicenter, open-label Phase 2 study. It is designed to evaluate Orca-T in adults with acute myeloid leukemia or myelodysplastic syndrome who are receiving reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will follow participants for GVHD-free and relapse-free survival for 365 days after transplantation. They will also track neutrophil engraftment (when new white blood cells start growing) for 28 days after transplantation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
At a glance
Conditions
Where it's being run
6 sites across 6 statesWho to contact
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What this trial measures
- RIC Cohort: GVHD-free and relapse-free survival (GRFS)Day 0 through day +365 after transplantation
GRFS is defined as the time from the date of transplantation to the date of death from any cause, relapse, the first onset of grade 3 or 4 acute GVHD (graded per MAGIC criteria), or the first onset of moderate or severe chronic GVHD (graded per NIH consensus criteria), whichever is earliest.
- NMA Cohort: Incidence of neutrophil engraftmentDay 0 through day +28 after transplantation
Incidence of neutrophil engraftment is defined as achieving an ANC ≥500/mm3 for 3 consecutive days by day +28. The first of the 3 days will be designated the day of engraftment. If the ANC never drops below 500/mm3, day +1 will be designated the day of engraftment.
- NMA Cohort: Time to neutrophil engraftmentDay 0 through day +28 after transplantation
The first of the 3 days will be designated the day of engraftment. If the ANC never drops below 500/mm3, day +1 will be designated the day of engraftment.