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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00801489
Phase
PHASE2
Status
Recruiting
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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
  • High Risk Myelodysplastic Syndrome
  • Inv(16)
  • Myelodysplastic Syndrome With Excess Blasts
  • Untreated Adult Acute Myeloid Leukemia
  • de Novo Myelodysplastic Syndrome
  • t(16;16)
  • t(8;21)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    Given IV
  • Decitabine — DRUG
    Given IV
  • Filgrastim-sndz — BIOLOGICAL
    Given SC
  • Fludarabine Phosphate — DRUG
    Given IV
  • Gemtuzumab Ozogamicin — DRUG
    Given IV
  • Idarubicin — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Apr 4, 2007
Status verified
Mar 2026
Primary completion
Oct 11, 2028
Completion
Oct 11, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
    See Detailed Description

Primary Outcome Measure

Complete remission rate [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Gautam Borthakur
713-563-1586
Gautam Borthakur (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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