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NCT04250051 · ClinicalTrials.gov registry record · Phase 1

Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia

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

Active
Registry status
Phase 1
Development phase
2
Enrollment target
1
Study location

NCT04250051: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Northwestern University.

NCT04250051 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 2 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04250051, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Northwestern University.

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

Study Summary

This phase I trial studies the side effects and best dose of ivosidenib when given together with combination chemotherapy for the treatment of 1DH1 mutant acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Ivosidenib may stop the growth of cancer cells by blocking the IDH1 mutation and some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and filgrastim, 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 ivosidenib with combination chemotherapy may work better in treating patients with acute myeloid leukemia compared to chemotherapy alone.

Primary Outcome

Will be assessed for a DLT per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Patients that complete the induction cycle will be eligible for assessment.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome Refractory Myelodysplastic Syndrome Recurrent Myeloproliferative Neoplasm

Interventions

  • DRUG Fludarabine
  • DRUG Cytarabine
  • BIOLOGICAL Filgrastim
  • DRUG Ivosidenib
  • DRUG Fludarabine Phosphate

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2020-12-21
Est. Completion 2028-12-01
Phase Phase 1
Northwestern University

1,209 total trials

What the registry record for NCT04250051 still lists

NCT04250051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (96% lower).

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

NCT04250051 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT04250051 about?

NCT04250051 is a clinical study titled "Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia". This phase I trial studies the side effects and best dose of ivosidenib when given together with combination chemotherapy for the treatment of 1DH1 mutant acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Ivosidenib may stop the growth of cancer cell...

What is the current status of trial NCT04250051?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2020-12-21. Estimated completion is 2028-12-01.

What conditions does trial NCT04250051 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Recurrent Myeloproliferative Neoplasm.

What interventions are being tested in trial NCT04250051?

The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Ivosidenib (DRUG), Fludarabine Phosphate (DRUG).

Who is sponsoring clinical trial NCT04250051?

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

Where is trial NCT04250051 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 NCT04250051's enrollment target sits among peer trials

2 63rd of 63 higher than 1 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 NCT04250051, the US trial registry maintained by the National Library of Medicine. NCT04250051 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.