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

NCT04250051 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-06-01

No results posted yet for this 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 is newly diagnosed (previously untreated), 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.

Conditions

  • Recurrent Acute Myeloid Leukemia
  • Recurrent Myelodysplastic Syndrome
  • Recurrent Myeloproliferative Neoplasm
  • Refractory Acute Myeloid Leukemia
  • Refractory Myelodysplastic Syndrome
  • Newly Diagnosed Acute Myeloid Leukemia (AML)
  • IDH1 Mutation Myeloid Neoplasms
  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Cytarabine

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine

Given IV

DRUG

Fludarabine Phosphate

Given IV

DRUG

Ivosidenib

Given PO

DRUG

Idarubicin

8 mg/m2 IV on days 4-6 of induction (cycle 1) and 8 g/m2 IV on days 4-6 of consolidation. Idarubicin will be administered per treating physician discretion. Idarubicin is a drug that belongs to a group of anti-cancer drugs called anthracyclines. These drugs were originally used as antibiotics, but it was subsequently found that they were effective anti-cancer drugs. Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake compared with other anthracyclines.

Sponsors & Collaborators

Principal Investigators

  • Shira N Dinner, M.D. · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2022-01-16
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250051 on ClinicalTrials.gov