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New treatment option for Acute Myeloid Leukemia
Official title Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT03737955
What this study is testing
What is Gemtuzumab Ozogamicin?
Gemtuzumab Ozogamicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as CDP-771, Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have received at least 1 cycle of standard induction chemotherapy prior to enrollment on the study. However, adult patients (\>= 18...
- Age \>= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
You likely can't join if
- people who have had chemotherapy or radiation therapy within 14 days prior to entering the study.
- people may not be receiving other investigational agents.
- Uncontrolled or concurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina...
See the full eligibility 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 (\<...
- 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...
- 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...
- 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
- people who have had chemotherapy or radiation therapy within 14 days prior to entering the study.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.