Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT03737955
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemtuzumab Ozogamicin — DRUG
    Receive IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug, called ozogamicin. 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 a chemotherapy known as calicheamicin to kill them.

Key Dates

First listed
Nov 13, 2018
Start date
Nov 30, 2018
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (gemtuzumab ozogamicin)
    Patients receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.

Primary Outcome Measure

Clinical response rate [ Time Frame: Up to 70 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer Center/University of Washington Cancer ConsortiumSeattleWashington98109
Mary-Elizabeth Percival
[email protected]
206-606-1320
Mary-Elizabeth Percival (PRINCIPAL_INVESTIGATOR)

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