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NCT03374332 · ClinicalTrials.gov registry record · Phase 2
Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Brown University.
- Active
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03374332: Active Phase 2 study of Acute Myeloid Leukemia, sponsored by Brown University.
NCT03374332 is a Phase 2 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Brown University. The registered enrollment target is 11 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03374332, a Phase 2 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Brown University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an infusion of blood cells called leukocytes from a donor, can stimulate the immune system to potentially fight the leukemia. Gemtuzmab ozogamicin is a class of drugs known as an antibody drug conjugate. The drug is given on days 1,4,7. It is infused, attaches to cells with a certain marker on the surface (the majority of which would be leukemia cells). The drug is then internalized and the chemotherapy drug becomes activated. Gemtuzumab is currently FDA approved for the treatment of acute myeloid leukemia. The infusion of leukocytes to stimulate the immune system to fight your leukemia is investigational and has not been proven to cure cancer. This combination of Gemtuzumab Ozogamicin and donor leukocytes is not an FDA approved treatment and is investigational. Initially a total of 6 patients will be included in the study to assess the safety of the treatment. Once 6 patients have been treated and no unacceptable toxicities are seen, more patients will be enrolled. The study will treat up to 18 patients on the study.
Primary Outcome
The MTD of non-engraftment donor leukocyte infusions administered with fractionated gemtuzumab ozogamicin in patients with relapsed/refractory AML is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs. The recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) was evaluated by utilizing a 3+3 design to determine if 1-2x108 CD3 cells/kg can be safely administered with fractionated Gemtuzumab Ozogamicin administered on days 1,4 and
Conditions Studied
Interventions
- DRUG Gemtuzumab Ozogamicin (GO)
- OTHER Donor Leukocytes
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-12-31 |
| Est. Completion | 2024-09 |
| Phase | Phase 2 |
What the registry record for NCT03374332 still lists
NCT03374332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Gemtuzumab Ozogamicin (GO) is the first listed.
NCT03374332 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT03374332 about?
NCT03374332 is a clinical study titled "Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia". This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an infusion of blood cells called...
What is the current status of trial NCT03374332?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2019-12-31. Estimated completion is 2024-09.
What conditions does trial NCT03374332 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03374332?
The interventions under investigation include: Gemtuzumab Ozogamicin (GO) (DRUG), Donor Leukocytes (OTHER).
Who is sponsoring clinical trial NCT03374332?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03374332 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03374332's enrollment target sits among peer trials
11 291st of 306 higher than 16 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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