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NCT03513484 · ClinicalTrials.gov registry record · Phase 1

Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, sponsored by Northwestern University.

Active
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT03513484: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, sponsored by Northwestern University.

NCT03513484 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 44 participants, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03513484, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Northwestern University.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. Investigational means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant's response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant's leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.

Primary Outcome

Will be defined as the highest dose that causes dose limiting toxicities (DLTs) in \< 2 of 6 patients.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Adult Acute Myeloid Leukemia Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Fibroblast Growth Factor Basic Form Measurement FLT3 Internal Tandem Duplication

Interventions

  • DRUG Azacitidine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Nintedanib

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2018-11-14
Est. Completion 2027-01
Phase Phase 1
Northwestern University

1,209 total trials

What the registry record for NCT03513484 still lists

NCT03513484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target.

The record links to 5 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Azacitidine is the first listed.

NCT03513484 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT03513484 about?

NCT03513484 is a clinical study titled "Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia". The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard inte...

What is the current status of trial NCT03513484?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2018-11-14. Estimated completion is 2027-01.

What conditions does trial NCT03513484 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Adult Acute Myeloid Leukemia, Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication.

What interventions are being tested in trial NCT03513484?

The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Nintedanib (DRUG).

Who is sponsoring clinical trial NCT03513484?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03513484 being conducted?

This trial has 1 study location across Illinois. 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 NCT03513484's enrollment target sits among peer trials

44 27th of 63 higher than 37 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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Related registry views

Source: ClinicalTrials.gov NCT03513484, the US trial registry maintained by the National Library of Medicine. NCT03513484 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.