CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 508 target
Drug / intervention
Cladribine +6 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓AML, Acute Biphenotypic Leukemia, or high-risk MDS (≥10% blasts or IPSS ≥intermediate-2)
  • ✓CML in Myeloid Blast Phase
  • ✓Frontline cohort: no prior potentially-curative therapy for leukemia
  • ✓Prior hydroxyurea, growth factors, azacytidine, decitabine, ATRA, or cytarabine up to 2g allowed for frontline
Key exclusion· 9
  • ✕Pregnant women
  • ✕Breastfeeding women
  • ✕Active uncontrolled infection
  • ✕Symptomatic congestive heart failure (NYHA Class III or IV)

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

Search/NCT02115295
NCT02115295Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML

M.D. Anderson Cancer Center·interventional·Posted Apr 16, 2014·Updated May 20, 2026

In Brief

A Phase 2 clinical trial evaluating Cladribine, Cytarabine, and 5 other interventions for Acute Biphenotypic Leukemia and 13 related conditions. Currently recruiting, targeting 508 participants across 1 site.

Detailed Summary

This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Biphenotypic Leukemia, Acute Myeloid Leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Blasts 10 Percent or More of Peripheral Blood White Cells, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Acute Myeloid Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Recruiting
20142015201620172018201920202021202220232024202520262027202820292030
First PostedApr 16, 2014
Enrollment StartMay 19, 2014
Primary CompletionMay 31, 2030
TodayJul 1, 2026
Enrollment to primary: 16.0 yearsPosted 12.2 years agoPrimary completion in 3.9 years

Interventions

Cladribinedrug

Given IV

Cytarabinedrug

Given IV

Gilteritinibdrug

Given PO

Idarubicindrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Midostaurindrug

Given PO

Venetoclaxdrug

Given PO