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NCT03214562 · ClinicalTrials.gov registry record · Phase 1
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
- 1
- Study location
NCT03214562: Recruiting Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT03214562 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 116 participants, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (152% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03214562, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.
Primary Outcome
Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + partial response (PR). Will be estimated along with the 95% credible interval.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Cytarabine
- DRUG Idarubicin
- BIOLOGICAL Filgrastim
- BIOLOGICAL Pegfilgrastim
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT03214562 shows while recruiting
NCT03214562 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (152% higher).
The record links to 3 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT03214562 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03214562 about?
NCT03214562 is a clinical study titled "Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia". This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may st...
What is the current status of trial NCT03214562?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2017-09-26. Estimated completion is 2027-09-30.
What conditions does trial NCT03214562 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome.
What interventions are being tested in trial NCT03214562?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT03214562?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03214562 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
Similar trials for Refractory Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03214562's enrollment target sits among peer trials
116 6th of 63 higher than 58 of 63 other Refractory Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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