Study on Fludarabine, Cytarabine, Filgrastim, Gemtuzumab, and Idarubicin for Treating Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00801489

Provider View

This clinical trial is testing a combination of chemotherapy and targeted therapy drugs to see how well they work and what side effects they cause in patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a combination of drugs, including fludarabine, cytarabine, filgrastim, gemtuzumab, and idarubicin, in treating patients who have been newly diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). These drugs work in different ways to stop cancer cells from growing, either by killing them or stopping them from dividing. Gemtuzumab is a targeted therapy that attaches to specific molecules on cancer cells to deliver a drug that kills them. Filgrastim helps the immune system recover from chemotherapy. The study aims to see if this combination can kill more cancer cells.

Description

The main goals of this study are to determine the safety of using a combination of fludarabine, cytarabine, filgrastim, gemtuzumab, and idarubicin in patients with untreated acute myeloid leukemia (AML) and to see how many patients achieve complete remission with this treatment.

The study will also look at how many patients remain in remission two years after treatment and whether certain tests can help detect if the cancer returns.

Treatment Plan:

  • Remission Induction: Patients will receive filgrastim daily to help blood cell recovery, along with fludarabine and cytarabine given through an IV over several days. Gemtuzumab will be given on the first day. If the cancer is not in remission after the first round, the treatment may be repeated.

  • Post-Remission Therapy: After achieving remission, patients will continue treatment with filgrastim, fludarabine, cytarabine, gemtuzumab, and idarubicin in cycles every 4-6 weeks, up to six times, unless the cancer progresses or side effects become too severe.

  • Further Treatment Adjustments: For patients over 60 or those with significant health issues, additional treatment with decitabine may be considered if needed, repeating every 4-6 weeks for up to 12 cycles.

After completing the study treatment, patients will have follow-up visits every six months for two years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must have newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific genetic markers (t(8;21), inv(16), or t(16;16)).
  • Must provide written consent to participate.
  • Patients with any level of physical activity or organ function can participate, but treatment may be adjusted based on individual health conditions.
  • Patients who have had one prior cycle of induction therapy may still join if they have specific genetic markers.
  • Patients of childbearing potential must use effective contraception.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.

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