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NCT03390296 · ClinicalTrials.gov registry record · Phase 1
OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT03390296: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03390296 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03390296, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as OX40, avelumab, and gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.
Primary Outcome
Response is: CR + complete response with incomplete recovery of platelets (CRp) + complete response with incomplete recovery of counts (CRi) within 3 months. CR: Bone Marrow blasts \</= 5%, Absolute neutrophil count \>/= 1,000, Platelets \>/= 100 and no extra medullary disease.CRp: Bone Marrow blasts \</= 5%, Absolute neutrophil count \>/= 1,000 and no extra medullary disease. CRi: Bone Marrow blasts \</= 5%
Interventions
- DRUG Azacitidine
- DRUG Gemtuzumab Ozogamicin
- DRUG Avelumab
- DRUG Glasdegib
- BIOLOGICAL Anti-OX40 Agonist Monoclonal Antibody PF-04518600
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-12-27 |
| Est. Completion | 2022-02-04 |
| Phase | Phase 1 |
What the finished NCT03390296 record still lists
NCT03390296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.
NCT03390296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03390296 about?
NCT03390296 is a clinical study titled "OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia". This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or doe...
What is the current status of trial NCT03390296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-12-27. Estimated completion is 2022-02-04.
What interventions are being tested in trial NCT03390296?
The interventions under investigation include: Azacitidine (DRUG), Gemtuzumab Ozogamicin (DRUG), Avelumab (DRUG), Glasdegib (DRUG), Anti-OX40 Agonist Monoclonal Antibody PF-04518600 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03390296?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03390296's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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