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NCT02397720 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT02397720: Completed Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT02397720 is a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 150 participants, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397720, a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a phase II, open-label, non-randomized study with a safety lead-in phase. There are 3 Arms in this study each with 2 parts. If you are eligible, you will be assigned to an Arm and a part when you join the study. In each arm, you will receive a different combination of study drugs: Arm 1: nivolumab and azacitidine, Ih Arm 2: nivolumab, azacitidine, and ipilimumab, Arm 3: nivolumab, azacitidine, and venetoclax. There are 2 parts in each arm: Part A (dose escalation) and Part B (dose expansion). The goal of Part A of this clinical research study is to find the highest tolerable dose of the study drugs (nivolumab, azacitidine, ipilimumab, and/or venetoclax) that can be given to patients with AML. The goal of Part B of this study is to learn if the dose found in Part A can help to control AML.
Primary Outcome
The maximum tolerated dose is defined as the highest dose level of 5-azacitidine with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Nivolumab
- DRUG Ipilimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-04-07 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 2 |
What the finished NCT02397720 record still lists
NCT02397720 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (27% lower).
The record links to 9 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT02397720 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02397720 about?
NCT02397720 is a clinical study titled "Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia". This will be a phase II, open-label, non-randomized study with a safety lead-in phase. There are 3 Arms in this study each with 2 parts. If you are eligible, you will be assigned to an Arm and a part when you join the study. In each arm, you will receive a different combination of study drugs: Arm 1...
What is the current status of trial NCT02397720?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2015-04-07. Estimated completion is 2023-10-09.
What conditions does trial NCT02397720 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome.
What interventions are being tested in trial NCT02397720?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02397720?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02397720 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02397720's enrollment target sits among peer trials
150 23rd of 134 higher than 112 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
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