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Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement

NCT03701295 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-10-18

Study results available
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Summary

This phase Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or is newly diagnosed, with an 11q23 rearrangement. Pinometostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

  • Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL
  • Leukemia Cutis
  • Recurrent Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia

Interventions

DRUG

Azacitidine

Given IV or SC

DRUG

Pinometostat

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kamal Menghrajani · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2020-12-08
Completion
2021-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701295 on ClinicalTrials.gov