CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 270 target
Drug / intervention
Cytarabine +6 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Untreated AML or high-risk MDS with t(8;21), inv(16), or t(16;16) cytogenetics
  • ✓Written informed consent required
  • ✓Up to one prior cycle of induction therapy allowed
  • ✓Patients of childbearing potential must use effective contraception
Key exclusion· 1
  • ✕Pregnant or lactating females

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00801489
NCT00801489Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
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A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia

M.D. Anderson Cancer Center·interventional·Posted Dec 3, 2008·Updated Mar 30, 2026

In Brief

A Phase 2 clinical trial evaluating Cytarabine, Decitabine, and 5 other interventions for Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 and 9 related conditions. Currently recruiting, targeting 270 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Recruiting
20072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
First PostedDec 3, 2008
Enrollment StartApr 4, 2007
Primary CompletionOct 11, 2028
TodayJul 2, 2026
Enrollment to primary: 21.5 yearsPosted 17.6 years agoPrimary completion in 2.3 years

Interventions

Cytarabinedrug

Given IV

Decitabinedrug

Given IV

Filgrastim-sndzbiological

Given SC

Fludarabine Phosphatedrug

Given IV

Gemtuzumab Ozogamicindrug

Given IV

Idarubicindrug

Given IV

Laboratory Biomarker Analysisother

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