Recruiting
Phase 2

Fludarabine, Cytarabine, Filgrastim-sndz, Gemtuzumab, Idarubicin

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00801489

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cytarabine

Decitabine

Filgrastim-sndz

Fludarabine Phosphate

Gemtuzumab Ozogamicin

Study Details

Brief 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

Study ID

NCT00801489

Start date

Apr 4, 2007

Status verified date

Mar, 2026

Completion date

Oct 11, 2028

Anticipated

Primary completion date

Oct 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, \[RAEB\], or RAEB "in transformation" \[RAEB-t\]) characterized by t(8;21), inv(16), or t(16;16); the presence of additional abnormalities is irrelevant
  • Patients must provide written consent
  • Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status >= to 3 the dosing schedule will be discussed with study chairman
  • Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine >= 1.5, cardiac ejection fraction =< 50%, total bilirubin >=2 and aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] >= 3 times upper limit of normal \[ULN\]), dose adjustments/omissions will be made
  • Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed; if the patient is in remission from induction therapy, he/she will receive post-remission therapy; if the patient is not in remission then he/she will receive induction therapy
  • Patients of child bearing potential should practice effective methods of contraception

Exclusion Criteria:

  • Pregnant and lactating females will be excluded

Study Design

Enrollment

270 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)

See Detailed Description

Interventions

Cytarabine

Given IV

Decitabine

Given IV

Filgrastim-sndz

Given SC

Fludarabine Phosphate

Given IV

Gemtuzumab Ozogamicin

Given IV

Idarubicin

Given IV

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gautam Borthakur

713-563-1586gborthak@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Gautam Borthakur

713-563-1586

Principal Investigator:

Gautam Borthakur

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-30.