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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 12, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial studies how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in participants with acute myeloid leukemia. Antibody-drug conjugates, such as gemtuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia CD33 Positive Minimal Residual Disease Drug: Gemtuzumab Ozogamicin Other: Quality-of-Life Assessment Phase 2

Detailed Description:

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. Non-responders without significant adverse events during the first course and responders, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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. Non-responders without significant adverse events during the first course and responders, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1.
Drug: Gemtuzumab Ozogamicin
Receive IV
Other Names:
  • CDP-771
  • Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody
  • Mylotarg

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Rate of allogeneic hematopoietic cell transplantation (HCT) [ Time Frame: Up to 6 Months ]
    Measured by those receiving HCT



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior diagnosis of AML based on 2016 World Health Organization criteria.
  • 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). Pediatric patients (2-18 years of age) must have MRD positivity during/after consolidation or post-transplant.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (for adults) or Lansky performance status >= 40 (for children).
  • 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).
  • For children (< 18 years of age): Glomerular filtration rate (GFR) in ml/min (age 2: 63-175; age 3-12: 89-165; females 13 and older: 75-115; males 13 and older: 85-125).
  • For children (< 18 years of age): Total bilirubin =< 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease).
  • For children (< 18 years of age): AST and ALT < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).
  • Ability of patient or representative to provide written informed consent.
  • Females of childbearing potential must have a negative pregnancy test prior to receiving GO.

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mary-Elizabeth Percival 206-606-1320 mperciva@seattlecca.org

Locations
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United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Mary-Elizabeth Percival         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mary-Elizabeth Percival Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03737955     History of Changes
Other Study ID Numbers: RG1018001
NCI-2018-01613 ( Registry Identifier: NCI / CTRP )
9966 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Gemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents