MedTrace Logo

Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

NCT00801489 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-03-30

No results posted yet for this study

Summary

This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.

Conditions

  • 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

Interventions

DRUG

Cytarabine

Given IV

DRUG

Decitabine

Given IV

BIOLOGICAL

Filgrastim-sndz

Given SC

DRUG

Fludarabine Phosphate

Given IV

DRUG

Gemtuzumab Ozogamicin

Given IV

DRUG

Idarubicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gautam Borthakur · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-04
Primary Completion
2028-10-11
Completion
2028-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00801489 on ClinicalTrials.gov