Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03737955|
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia CD33 Positive Minimal Residual Disease||Drug: Gemtuzumab Ozogamicin Other: Quality-of-Life Assessment||Phase 2|
Participants 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, participants are followed up for 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)|
|Actual Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||August 15, 2021|
|Estimated Study Completion Date :||August 15, 2021|
Experimental: Treatment (gemtuzumab ozogamicin)
Participants 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.
Drug: Gemtuzumab Ozogamicin
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Clinical response rate [ Time Frame: Up to 70 days ]Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.
- Rate of sinusoidal obstructive syndrome (SOS) [ Time Frame: Up to 6 months ]Measured by grade III/IV non-hematologic toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
- Rate of allogeneic hematopoietic cell transplantation (HCT) [ Time Frame: Up to 6 Months ]Measured by those receiving HCT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737955
|Contact: Mary-Elizabeth Percivalfirstname.lastname@example.org|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Mary-Elizabeth Percival|
|Principal Investigator:||Mary-Elizabeth Percival||Fred Hutch/University of Washington Cancer Consortium|