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NCT05115630 · ClinicalTrials.gov registry record · Phase 2
Off-the-shelf NK Cells + SCT for Myeloid Malignancies
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05115630: Completed Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
NCT05115630 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 24 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05115630, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn about the safety and effectiveness of giving KDS-1001 in combination with a standard stem cell transplant to patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML). KDS-1001 is a study product created using certain immune cells called natural killer (NK) cells collected from a third-party donor.
Primary Outcome
Primary Graft failure is defined as failure to achieve an ANC \> 0.5 x 109/L for 3 consecutive days by day 28 post SC infusion, with no evidence of donor derived cells by bone marrow chimerism studies and no evidence of persistent or relapsing disease.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Melphalan
- DRUG Mesna
- DRUG Fludarabine phosphate
- DRUG Filgrastim
Study Locations (1)
Texas
- M D Anderson Caner Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-04-08 |
| Est. Completion | 2025-05-15 |
| Phase | Phase 2 |
What the finished NCT05115630 record still lists
NCT05115630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05115630 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05115630 about?
NCT05115630 is a clinical study titled "Off-the-shelf NK Cells + SCT for Myeloid Malignancies". The goal of this clinical research study is to learn about the safety and effectiveness of giving KDS-1001 in combination with a standard stem cell transplant to patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML). KDS-1001 is a study product...
What is the current status of trial NCT05115630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2022-04-08. Estimated completion is 2025-05-15.
What conditions does trial NCT05115630 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Myeloid Malignancies.
What interventions are being tested in trial NCT05115630?
The interventions under investigation include: Cyclophosphamide (DRUG), Melphalan (DRUG), Mesna (DRUG), Fludarabine phosphate (DRUG), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT05115630?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05115630 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05115630's enrollment target sits among peer trials
24 225th of 306 higher than 75 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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