Acute Myeloid Leukemia Clinical Trial

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

Summary

Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment.

Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a specifiedthe assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification

Patients with AML must meet one of the following criteria, a or b:

Primary Induction Failure (PIF) AML, defined as disease refractory to either, i or ii:

i. An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens. Examples include but are not limited to: 1 cycle of high dose cytarabine (HiDAC) containing regimen, 1 cycle of liposomal cytarabine and daunorubicin, 2 cycles of standard dose cytarabine containing regimen
ii. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens: i ≥ 2 but ≤ 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine, or ii ≥ 2 but ≤ 4 cycles of gemtuzumab ozogamicin monotherapy
Early relapse (ER) AML, defined as AML in first relapse with initial CR1 duration < 6 months
Limit of 3 prior lines of therapy (excluding focal radiation therapy for palliative purposes): up to 2 induction (induction, re-induction) or 1 induction plus/minus 1 consolidation attempt, followed by a maximum of 1 salvage/re-induction attempt.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy of at least 4 weeks
Peripheral blast count Acceptable laboratory parameters and adequate organ reserve

Exclusion Criteria:

History of allogeneic stem cell transplantation
Prior treatment with an anti-CD123-directed agent
Need for concurrent other cytoreductive chemotherapy
Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)
Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1.
Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution
Use of immunosuppressant medications in the 2 weeks prior to Cycle 1 Day 1
Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to Cycle 1 Day 1
Known central nervous system (CNS) leukemia
Active uncontrolled infection (including, but not limited to viral, bacterial, fungal, or mycobacterial infection),
Known human immunodeficiency virus infection, unless all of the following criteria are met: CD4+ count ≥ 350 cells/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
Known, active, history of or current acute or chronic hepatitis B or C virus (HBV) infection (as evidenced by detectable HBV surface antigen and HBV DNA ≥ 500 IU/mL),
History of hepatitis C virus (HCV) infection, unless the infection has been treated and cured,
Active SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing for ongoing infection should follow local clinical practice guidelines/standards. Participants with a positive test result for ongoing SARS-CoV-2 infection, known asymptomatic infection, or suspected infection are excluded unless or until asymptomatic and with subsequent negative SARS-CoV-2 laboratory test.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

244

Study ID:

NCT02152956

Recruitment Status:

Terminated

Sponsor:

MacroGenics

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There are 38 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
UCSD Moores Cancer Center
La Jolla California, 92093, United States
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
University of California, San Francisco
San Francisco California, 94143, United States
Georgetown University - Lombardi Cancer Center
Washington District of Columbia, 20057, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Emory University
Atlanta Georgia, 30322, United States
Loyola University Chicago - Cardinal Bernadin Cancer Center
Maywood Illinois, 60153, United States
University of Maryland
Baltimore Maryland, 21201, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Stony Brook Medicine
Stony Brook New York, 11794, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Institut Paoli-Calmettes
Marseille , 13002, France
Centre Hospitalier Universitaire de Nantes
Nantes , 44093, France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse , 31059, France
CHRU de Tours - Hôpital Bretonneau
Tours , 37044, France
Charité - Universitätsmedizin Berlin
Berlin , 13353, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden , 01307, Germany
Universitätsklinik Hamburg-Eppendorf
Hamburg , 20246, Germany
Universitätsklinikum Leipzig
Leipzig , 04103, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz , 55131, Germany
III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München
Munich , 81675, Germany
Medizinische Klinik und II, Universitätsklinikum Würzburg
Würzbur , 97080, Germany
Rambam Health Care Campus
Haifa , , Israel
Shaare Zedek Medical Center
Jerusalem , , Israel
Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola , 74014, Italy
University Vita-Salute San Raffaele
Milano , 20132, Italy
Unità Operativa di Ematologia Ospedale Santa Maria delle Croci
Ravenna , 48123, Italy
University Medical Center Groningen
Groningen , 9713, Netherlands
Erasmus University Medical Center
Rotterdam , 3075, Netherlands
Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau
Barcelona , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
King's Health Partners
London , , United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

244

Study ID:

NCT02152956

Recruitment Status:

Terminated

Sponsor:


MacroGenics

How clear is this clinincal trial information?

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