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RecruitingPhase 2

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

A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 35 days, 6 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity."
  • "Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial."
  • "After completion of study treatment, patients are followed up for 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well gemtuzumab ozogamicin, given in divided doses, treats small amounts of leukemia left after treatment. It is for adults with acute myeloid leukemia (AML), a blood cancer. The drug attaches to a marker called CD33 on cancer cells and delivers chemotherapy to kill them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older and have AML. Two types, acute promyelocytic leukemia (APL) and biphenotypic AML, are not eligible.
  • Only small amounts of leukemia may remain, confirmed by special lab tests. Your bone marrow must have fewer than 5% immature cancer cells; blood counts do not need to be back to normal.
  • You must have had at least 1 round of standard chemotherapy to bring AML into remission. You may join at any later treatment stage, including before or after a transplant.
  • Your leukemia cells must have the CD33 marker.
  • Your ability to do daily activities must meet the study's rating of 3 or lower. At this level, you can do some self-care but may spend more than half the day in bed or a chair.
  • Kidney and liver blood tests must meet study limits: creatinine at most 2.0 mg/dL, bilirubin at most twice the normal upper limit, and AST and ALT below 2.5 times that limit. Some liver test exceptions apply.
  • You must be able to give written consent. If you can become pregnant, you must have a negative pregnancy test before getting the study drug.
  • If you join again, your earlier study treatment must have led to remission with no remaining leukemia found by special tests.

Who can't join

  • You had chemotherapy or radiation within 14 days before joining.
  • You are receiving another experimental treatment.
  • You have an uncontrolled illness or another condition that could keep you from following study rules. Examples include uncontrolled infection, heart failure with symptoms, unstable chest pain, an abnormal heartbeat, mental illness, or social problems.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

WA