Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or High-Risk Myeloproliferative Neoplasm

NCT03737955

Last updated date
Study Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Contact
206-606-1320

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Prior diagnosis of either high-risk myelodysplastic syndrome (myelodysplastic syndrome [MDS]; defined as >= 10% blasts in bone marrow or blood), high-risk myeloproliferative neoplasms (myeloproliferative neoplasms [MPN]; defined as >= 10% blasts in bone marrow or blood), or 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). Pediatric patients (2-18 years of age) must have MRD positivity during/after consolidation or post-transplant.

- Age >= 2 years of age

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative NeoplasmFractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or High-Risk Myeloproliferative Neoplasm
NCT03737955
  1. Seattle, Washington
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or High-Risk Myeloproliferative Neoplasm
Official Title  ICMJE A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)
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, high-risk myelodysplastic syndrome or high-risk myeloproliferative neoplasm. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Treatment (gemtuzumab ozogamicin)
Patients 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.
Interventions:
  • Drug: Gemtuzumab Ozogamicin
  • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2021
Estimated Primary Completion Date August 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prior diagnosis of either high-risk myelodysplastic syndrome (myelodysplastic syndrome [MDS]; defined as >= 10% blasts in bone marrow or blood), high-risk myeloproliferative neoplasms (myeloproliferative neoplasms [MPN]; defined as >= 10% blasts in bone marrow or blood), or 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). Pediatric patients (2-18 years of age) must have MRD positivity during/after consolidation or post-transplant.
  • Age >= 2 years of age
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary-Elizabeth Percival206-606-1320[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737955
Other Study ID Numbers  ICMJE RG1018001
NCI-2018-01613 ( Registry Identifier: NCI / CTRP )
9966 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Mary-Elizabeth PercivalFred Hutch/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP