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NCT04151706 · ClinicalTrials.gov registry record · Phase 2
CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Robert Lowsky.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT04151706: Completed Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Robert Lowsky.
NCT04151706 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that has completed, run by Robert Lowsky. The registered enrollment target is 7 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04151706, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Robert Lowsky.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.
Primary Outcome
The rate of participants who do not experience GvHD and also do not experience relapse are collectively considered to be GRFS. Relapse will be assessed according to the myelodysplastic syndrome or leukemia response criteria. The participants will be assessed for GRFS though 1 year post transplant. The outcome will be reported as the number of participants, a number without dispersion.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Thiotepa
- DRUG CD8+ Memory T Cell Infusion
- RADIATION Hyperfractionated TBI
Study Locations (1)
California
- Stanford Medical Center - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 2 |
What the finished NCT04151706 record still lists
NCT04151706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT04151706 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04151706 about?
NCT04151706 is a clinical study titled "CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML". This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.
What is the current status of trial NCT04151706?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2020-02-27. Estimated completion is 2023-09-08.
What conditions does trial NCT04151706 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Acute Leukemia, Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT04151706?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Thiotepa (DRUG), CD8+ Memory T Cell Infusion (DRUG), Hyperfractionated TBI (RADIATION).
Who is sponsoring clinical trial NCT04151706?
This trial is sponsored by Robert Lowsky, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04151706 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04151706's enrollment target sits among peer trials
7 299th of 306 higher than 5 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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