CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 51 target
Drug / intervention
Azacitidine +8 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Age ≥18 years at time of informed consent
  • ✓Morphologically documented relapsed/refractory AML or secondary AML progressed after ≥1 prior therapy
  • ✓MDS progressed on hypomethylating agent therapy and ineligible for intensive chemotherapy
  • ✓ECOG performance status 0-2
Key exclusion· 21
  • ✕Diagnosis of acute promyelocytic leukemia (APL or AML M3)
  • ✕Active CNS involvement with AML
  • ✕Recent chemotherapy or non-investigational agent within 1 week except hydroxyurea or per PI discretion
  • ✕Non-biologic investigational agent within 14 days or 5 half-lives whichever is longer

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

Search/NCT03874052
NCT03874052Phase 1RecruitingOn TrackUpdated 3mo ago
Long Recruiting
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Phase I Study to Evaluate Safety of Ruxolitinib in Combination With Azacitidine + Venetoclax in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Jennifer Saultz·interventional·Posted Mar 14, 2019·Updated Mar 24, 2026

In Brief

A Phase 1 clinical trial evaluating Azacitidine, Biospecimen Collection, and 7 other interventions for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and 4 related conditions. Currently recruiting, targeting 51 participants across 3 sites.

Detailed Summary

This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and/or effective compare to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Secondary Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Refractory Secondary Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsAbbVie, Incyte Corporation, Oregon Health and Science University

Timeline

Phase 1Recruiting
2019202020212022202320242025202620272028
First PostedMar 14, 2019
Enrollment StartAug 16, 2019
Primary CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 7.3 years agoPrimary completion in 1.5 years

Interventions

Azacitidinedrug

Given IV or SC

Biospecimen Collectionprocedure

Undergo blood sample collection

Bone Marrow Aspirationprocedure

Undergo bone marrow aspiration and biopsy

Bone Marrow Biopsyprocedure

Undergo bone marrow aspiration and biopsy

Echocardiography Testprocedure

Undergo ECHO

Punch Biopsyprocedure

Undergo skin punch biopsy

Questionnaire Administrationother

Ancillary studies

Ruxolitinibdrug

Given PO

Venetoclaxdrug

Given PO