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New cocktail of 5 drugs targets tough leukemia

NCT ID NCT00801489

Recruiting now Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial is testing a combination of five drugs (fludarabine, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin) in 270 people with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome that have specific genetic changes. The goal is to see how well the treatment works and what side effects it causes. The drugs work together to kill cancer cells and help the immune system recover from chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
fludarabine, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, idarubicin
What this could lead to
If this works, it could offer a more effective treatment option for people with certain genetic types of acute myeloid leukemia or high-risk myelodysplastic syndrome.
What could go wrong
This is a phase 2 trial, so it's still early. The combination of drugs may cause severe side effects, and it's not yet known if it will improve survival compared to standard treatments.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with t(6;9)(p23;q34) acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myeloid leukemia, t(8;21)(q22; q22.1) chromosome inversion disorder Leukemia, Myelomonocytic, Acute myelodysplastic syndrome myelodysplastic syndrome with excess blasts

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKEMIA WITH INV(16)(P13.1Q22); CBFB-MYH11 ACUTE MYELOID LEUKEMIA WITH T(16;16)(P13.1;Q22); CBFB-MYH11 ACUTE MYELOID LEUKEMIA WITH T(8;21); (Q22; Q22.1); RUNX1-RUNX1T1 DE NOVO MYELODYSPLASTIC SYNDROME HIGH RISK MYELODYSPLASTIC SYNDROME INV(16) MYELODYSPLASTIC SYNDROME WITH EXCESS BLASTS T(16;16) T(8;21) UNTREATED ADULT ACUTE MYELOID LEUKEMIA

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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