Clinical trial NCT03737955: Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia
Official title: A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Myeloid and Monocytic Leukemia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OUTLINE:

Patients receive gemtuzumab ozogamicin intravenously (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.

After completion of study treatment, patients are followed up for 6 months.

Eligibility criteria: Inclusion Criteria:

* Prior diagnosis AML based on 2016 World Health Organization criteria. Acute promyelocytic leukemia (APL) and biphenotypic AML are not eligible
* Patients must have MRD-level disease only and otherwise meet criteria for complete response (CR) or complete remission with incomplete hematologic recovery (CRi) per the 2017 European Leukemia Net response criteria (\< 5% blasts in the marrow without a requirement for peripheral blood count recovery). MRD must be measurable by multiparameter flow cytometry (MPFC) and/or polymerase chain reaction (PCR)-based molecular markers and/or karyotypic markers (e.g., classical cytogenetics or fluorescence in situ hybridization). MRD status will be centrally confirmed by the UW/FHCRC clinical laboratory in order to standardize response assessment following administration of study therapy.
* Patients must have received at least 1 cycle of standard induction chemotherapy prior to enrollment on the study. However, adult patients (\>= 18 years of age) are eligible for participation at any time point in treatment (after induction, during or after consolidation, pre-transplant, or post-transplant).
* Age \>= 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
* Patient's AML blasts must have CD33 expression.
* For adults (\>= 18 years of age): Serum creatinine =\< 2.0 mg/dL.
* For adults (\>= 18 years of age): Total bilirubin =\< 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease).
* For adults (\>= 18 years of age): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).
* Ability of patient to provide written informed consent.
* Females of childbearing potential must have a negative pregnancy test prior to receiving GO.
* Patients who re-enroll must have achieved an MRD-negative CR during their prior enrollment

Exclusion Criteria:

* Subjects who have had chemotherapy or radiation therapy within 14 days prior to entering the study.
* Subjects may not be receiving other investigational agents.
* Uncontrolled or concurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Clinical response rate
timeFrame: Up to 70 days
Secondary outcomes:
measure: Rate of sinusoidal obstructive syndrome (SOS)
timeFrame: Up to 6 months
measure: Rate of allogeneic hematopoietic cell transplantation (HCT)
timeFrame: Up to 6 Months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Mary-Elizabeth Percival
role: PRINCIPAL_INVESTIGATOR
References: