JOURNAL ONKOLOGIE – STUDIE
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Rekrutierend
NCT-Nummer:
NCT02152956
Studienbeginn:
Juni 2014
Letztes Update:
06.01.2021
Wirkstoff:
Flotetuzumab
Indikation (Clinical Trials):
Leukemia, Myeloid, Acute
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
MacroGenics
Collaborator:
Institut de Recherches Internationales Servier
Studienleiter
Principal Investigator
Washington University School of Medicine
Study Director
MacroGenics
Principal Investigator
Institute Paoli-Calmettes
Kontakt
Kontakt:
E-Mail: trank@Macrogenics.com» Kontaktdaten anzeigen
Studienlocations (3 von 35)
Charité - Universitätsmedizin Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Margrit Stodder
Phone: +49 30 450553862
E-Mail: Margrit.stodder@charite.de» Ansprechpartner anzeigenUniversitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Max Langner
E-Mail: max.langner@uniklinikum-dresden.de» Ansprechpartner anzeigenUniversitätsklinik Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Petra Kuhne
Phone: +040 741054353
E-Mail: p.kuehne@uke.de» Ansprechpartner anzeigen
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Margrit Stodder
Phone: +49 30 450553862
E-Mail: Margrit.stodder@charite.de» Ansprechpartner anzeigenUniversitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Max Langner
E-Mail: max.langner@uniklinikum-dresden.de» Ansprechpartner anzeigenUniversitätsklinik Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Petra Kuhne
Phone: +040 741054353
E-Mail: p.kuehne@uke.de» Ansprechpartner anzeigen
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Karolin Hubert
Phone: + 49 341 97-20363
E-Mail: karolin.hubert@medizin.uni-leipzig.de» Ansprechpartner anzeigenUniversitätsmedizin der Johannes Gutenberg-Universität Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Britta Vornwald
Phone: +49 6131 17 5160
E-Mail: britta.vornwald@unimedizin-mainz.de» Ansprechpartner anzeigenIII. Med. Klinik-Klinikum rechts der Isar-Technische Universität München
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christine Ernst
Phone: +49 89 41405145
E-Mail: christine.ernst@mri.tum.de» Ansprechpartner anzeigenMedizinische Klinik und II, Universitätsklinikum Würzburg
97080 Würzbur
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Johana Reif
E-Mail: Reif_J@ukw.de» Ansprechpartner anzeigenCity of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dianne Yu
Phone: 626-256-4672
Phone (ext.): 83524
E-Mail: diyu@coh.org» Ansprechpartner anzeigenUCSD Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Marisa Wiegand
Phone: 858-822-6396
E-Mail: mwiegand@ucsd.edu
Emma Bishop
Phone: 858-822-1960
E-Mail: e2Bishop@ucsd.edu» Ansprechpartner anzeigenUniversity of California, San Francisco
94143 San Francisco
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Caroline Nattinger
Phone: 415-514-4805
E-Mail: Caroline.Nattinger@ucsf.edu» Ansprechpartner anzeigenMoffitt Cancer Center
33612 Tampa
United StatesAbgeschlossen» Google-MapsEmory University
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Shannon Gleason
Phone: 404-778-4334
E-Mail: Shannon.gleason@emory.edu» Ansprechpartner anzeigenUniversity of Maryland
21201 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Veronica Kflu
Phone: 410-328-9416
E-Mail: veronica.kflu@umm.edu» Ansprechpartner anzeigenUniversity of Michigan
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Roxana Taralunga
Phone: 734-232-0773
E-Mail: roxanat@med.umich.edu» Ansprechpartner anzeigenWashington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ayan Gasanli
Phone: 314-747-2449
E-Mail: agasanli@wustl.edu» Ansprechpartner anzeigenUniversity of North Carolina Lineberger Comprehensive Cancer Center
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Allison McKinney
Phone: 919-966-4432
E-Mail: allison_mckinney@med.unc.edu» Ansprechpartner anzeigenDuke University Medical Center
27710 Durham
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Rachel Stowe, BSN, RN
Phone: 919-681-4769
E-Mail: rachel.stowe@duke.edu» Ansprechpartner anzeigenCleveland Clinic
44195 Cleveland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Kaylee Root
Phone: 216-444-3576
E-Mail: ROOTK2@ccf.org
Eric Wiedenfeld
Phone: 216-445-0003
E-Mail: wiedene@ccf.org» Ansprechpartner anzeigenProvidence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Neysa Dagostino, RN, OCN
Phone: 503-215-2608
E-Mail: neysa.dagostino@providence.org» Ansprechpartner anzeigenVanderbilt-Ingram Cancer Center
37232 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dino Francescutti
Phone: 615-875-9980
E-Mail: dino.francescutti@vumc.org» Ansprechpartner anzeigenThe University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Melissa J. McFarland
Phone: 713-745-1216
E-Mail: MJMacFarland@mdanderson.org» Ansprechpartner anzeigenFred Hutchinson Cancer Research Center
98109 Seattle
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Cherise Athay
E-Mail: cathay@fredhutch.org» Ansprechpartner anzeigenMedical College of Wisconsin
53226 Milwaukee
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Katelyn Gauger
Phone: 414-805-4587
E-Mail: kgauger@mcw.edu» Ansprechpartner anzeigenInstitut Paoli-Calmettes
13002 Marseille
FranceRekrutierend» Google-Maps
Ansprechpartner:
Caroline Veuillen
E-Mail: veuillenc@ipc.unicancer.fr» Ansprechpartner anzeigenCentre Hospitalier Universitaire de Nantes
44093 Nantes
FranceRekrutierend» Google-Maps
Ansprechpartner:
Lea Robert
E-Mail: lea.robert@chu-nantes.fr» Ansprechpartner anzeigenInstitut Universitaire du Cancer de Toulouse-Oncopole
31059 Toulouse
FranceRekrutierend» Google-Maps
Ansprechpartner:
Elodi Judic
Phone: +33 5 31 15 58 74
E-Mail: judic.elodie@iuct-oncopole.fr» Ansprechpartner anzeigenCHRU de Tours - Hôpital Bretonneau
37044 Tours
FranceRekrutierend» Google-Maps
Ansprechpartner:
Hiba El Sayadi Bizri
E-Mail: H.BIZRIELSAYADI@chu-tours.fr» Ansprechpartner anzeigenPoliclinico Sant'Orsola Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Cinzia Bonajuto
E-Mail: cinzia.bonajuto@studio.unibo.it» Ansprechpartner anzeigenIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
74014 Meldola
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Frederica Frabetti
Phone: 390543739292
E-Mail: federica.frabetti@irst.emr.it» Ansprechpartner anzeigenUniversity Vita-Salute San Raffaele
20132 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Stefania Trinca
E-Mail: trinca.stefania@hsr.it» Ansprechpartner anzeigenUnità Operativa di Ematologia Ospedale Santa Maria delle Croci
48123 Ravenna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Francesca Fabbri
Phone: 0039 054 428 5103
E-Mail: francesca.fabbri@irst.emr.it» Ansprechpartner anzeigenUniversity Medical Center Groningen
9713 Groningen
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Erna Helmantel
E-Mail: e.helmantel@umcg.nl» Ansprechpartner anzeigenErasmus University Medical Center
3075 Rotterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Sarah Longergan
E-Mail: s.lonergan@erasmusmc.nl» Ansprechpartner anzeigenKing's Health Partners
London
United KingdomNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Lajos Floro
Phone: 44 20 3299 5777
E-Mail: lajos.floro@nhs.net» Ansprechpartner anzeigenThe Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Ryan Roberts
Phone: +44 161 446 3000
E-Mail: Ryanjames.Roberts@christie.nhs.uk» Ansprechpartner anzeigen
Alle anzeigen 4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Karolin Hubert
Phone: + 49 341 97-20363
E-Mail: karolin.hubert@medizin.uni-leipzig.de» Ansprechpartner anzeigenUniversitätsmedizin der Johannes Gutenberg-Universität Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Britta Vornwald
Phone: +49 6131 17 5160
E-Mail: britta.vornwald@unimedizin-mainz.de» Ansprechpartner anzeigenIII. Med. Klinik-Klinikum rechts der Isar-Technische Universität München
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christine Ernst
Phone: +49 89 41405145
E-Mail: christine.ernst@mri.tum.de» Ansprechpartner anzeigenMedizinische Klinik und II, Universitätsklinikum Würzburg
97080 Würzbur
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Johana Reif
E-Mail: Reif_J@ukw.de» Ansprechpartner anzeigenCity of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dianne Yu
Phone: 626-256-4672
Phone (ext.): 83524
E-Mail: diyu@coh.org» Ansprechpartner anzeigenUCSD Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Marisa Wiegand
Phone: 858-822-6396
E-Mail: mwiegand@ucsd.edu
Emma Bishop
Phone: 858-822-1960
E-Mail: e2Bishop@ucsd.edu» Ansprechpartner anzeigenUniversity of California, San Francisco
94143 San Francisco
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Caroline Nattinger
Phone: 415-514-4805
E-Mail: Caroline.Nattinger@ucsf.edu» Ansprechpartner anzeigenMoffitt Cancer Center
33612 Tampa
United StatesAbgeschlossen» Google-MapsEmory University
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Shannon Gleason
Phone: 404-778-4334
E-Mail: Shannon.gleason@emory.edu» Ansprechpartner anzeigenUniversity of Maryland
21201 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Veronica Kflu
Phone: 410-328-9416
E-Mail: veronica.kflu@umm.edu» Ansprechpartner anzeigenUniversity of Michigan
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Roxana Taralunga
Phone: 734-232-0773
E-Mail: roxanat@med.umich.edu» Ansprechpartner anzeigenWashington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ayan Gasanli
Phone: 314-747-2449
E-Mail: agasanli@wustl.edu» Ansprechpartner anzeigenUniversity of North Carolina Lineberger Comprehensive Cancer Center
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Allison McKinney
Phone: 919-966-4432
E-Mail: allison_mckinney@med.unc.edu» Ansprechpartner anzeigenDuke University Medical Center
27710 Durham
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Rachel Stowe, BSN, RN
Phone: 919-681-4769
E-Mail: rachel.stowe@duke.edu» Ansprechpartner anzeigenCleveland Clinic
44195 Cleveland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Kaylee Root
Phone: 216-444-3576
E-Mail: ROOTK2@ccf.org
Eric Wiedenfeld
Phone: 216-445-0003
E-Mail: wiedene@ccf.org» Ansprechpartner anzeigenProvidence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Neysa Dagostino, RN, OCN
Phone: 503-215-2608
E-Mail: neysa.dagostino@providence.org» Ansprechpartner anzeigenVanderbilt-Ingram Cancer Center
37232 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dino Francescutti
Phone: 615-875-9980
E-Mail: dino.francescutti@vumc.org» Ansprechpartner anzeigenThe University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Melissa J. McFarland
Phone: 713-745-1216
E-Mail: MJMacFarland@mdanderson.org» Ansprechpartner anzeigenFred Hutchinson Cancer Research Center
98109 Seattle
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Cherise Athay
E-Mail: cathay@fredhutch.org» Ansprechpartner anzeigenMedical College of Wisconsin
53226 Milwaukee
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Katelyn Gauger
Phone: 414-805-4587
E-Mail: kgauger@mcw.edu» Ansprechpartner anzeigenInstitut Paoli-Calmettes
13002 Marseille
FranceRekrutierend» Google-Maps
Ansprechpartner:
Caroline Veuillen
E-Mail: veuillenc@ipc.unicancer.fr» Ansprechpartner anzeigenCentre Hospitalier Universitaire de Nantes
44093 Nantes
FranceRekrutierend» Google-Maps
Ansprechpartner:
Lea Robert
E-Mail: lea.robert@chu-nantes.fr» Ansprechpartner anzeigenInstitut Universitaire du Cancer de Toulouse-Oncopole
31059 Toulouse
FranceRekrutierend» Google-Maps
Ansprechpartner:
Elodi Judic
Phone: +33 5 31 15 58 74
E-Mail: judic.elodie@iuct-oncopole.fr» Ansprechpartner anzeigenCHRU de Tours - Hôpital Bretonneau
37044 Tours
FranceRekrutierend» Google-Maps
Ansprechpartner:
Hiba El Sayadi Bizri
E-Mail: H.BIZRIELSAYADI@chu-tours.fr» Ansprechpartner anzeigenPoliclinico Sant'Orsola Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Cinzia Bonajuto
E-Mail: cinzia.bonajuto@studio.unibo.it» Ansprechpartner anzeigenIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
74014 Meldola
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Frederica Frabetti
Phone: 390543739292
E-Mail: federica.frabetti@irst.emr.it» Ansprechpartner anzeigenUniversity Vita-Salute San Raffaele
20132 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Stefania Trinca
E-Mail: trinca.stefania@hsr.it» Ansprechpartner anzeigenUnità Operativa di Ematologia Ospedale Santa Maria delle Croci
48123 Ravenna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Francesca Fabbri
Phone: 0039 054 428 5103
E-Mail: francesca.fabbri@irst.emr.it» Ansprechpartner anzeigenUniversity Medical Center Groningen
9713 Groningen
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Erna Helmantel
E-Mail: e.helmantel@umcg.nl» Ansprechpartner anzeigenErasmus University Medical Center
3075 Rotterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Sarah Longergan
E-Mail: s.lonergan@erasmusmc.nl» Ansprechpartner anzeigenKing's Health Partners
London
United KingdomNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Lajos Floro
Phone: 44 20 3299 5777
E-Mail: lajos.floro@nhs.net» Ansprechpartner anzeigenThe Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Ryan Roberts
Phone: +44 161 446 3000
E-Mail: Ryanjames.Roberts@christie.nhs.uk» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description: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 (ongoing). 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.
Ein-/Ausschlusskriterien
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:
a. Primary Induction Failure (PIF) AML, defined as disease refractory to one of the
following, 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. One cycle of high dose cytarabine (HiDAC) containing regimen
2. One cycle of liposomal cytarabine and daunorubicin
3. Two 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, 1 or 2:
1. ≥ 2 but ≤ 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or
low dose cytarabine 2. ≥ 2 but ≤ 4 cycles of gemtuzumab ozogamicin monotherapy b. Early
relapse (ER) AML, defined as AML in first relapse with initial CR1 duration < 6 months 3.
Limit of 3 prior lines of therapy: 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 = 20,000/mm3 at the time of first dose
- 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, nasal spray or ophthalmic
solution
- Use of immunosuppressant medications in the 2 weeks of Cycle 1 Day 1
- Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating
factor in the 2 weeks of 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:
i. CD4+ count ≥ 350 cells/μL, ii. undetectable viral load, and iii. 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 COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for
study entry, testing should follow local clinical practice guidelines/standards.
Participants with a positive test result for SARS-CoV-2 infection, known asymptomatic
infection, or suspected infection are excluded.
Studien-Rationale
Primary outcome:1. Efficacy based on CR/CRh rate (Time Frame - 14 months):
Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], molecular CR [CRm], or CRh per Interworking Group AML response criteria.
Secondary outcome:
1. Overall complete response rate (Time Frame - 14 months):
Rate of CR + CRh + CRi (CR with incomplete blood cell recovery [CR with incomplete neutrophil or platelet recovery]) + MLFS (morphologic leukemia-free state)
2. CR rate (Time Frame - 14 months):
Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], or molecular CR [CRm] per Interworking Group AML response criteria.
3. CRh rate (Time Frame - 14 months):
Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.
4. Duration of response (Time Frame - Up to 2 years):
Time of initial documentation of response to the time of disease relapse, progression, or death due to any cause, whichever occurs first.
5. Transfusion independence rate (Time Frame - 56 days):
The rate of conversion from transfusion dependence to transfusion independence will be calculated. The rate of patients who are transfusion independent at baseline and remain independent during any 56-day post-baseline period will also be calculated.
6. Overall survival (Time Frame - Up to 2 years):
Time from first dose to death from any cause
7. HSCT rate (Time Frame - 8 months):
Rate of successful hematopoietic stem cell transplantation (HSCT) through flotetuzumab treatment but before subsequent therapy.
8. Incidence rate of hospitalization (Time Frame - 8 months):
Incidence rate of hospitalization will be calculated
9. Duration of hospitalization (Time Frame - 8 months):
Duration of hospitalization will be characterized
10. Event-free survival (Time Frame - Up to 2 years):
Time from the first dose of study drug until date of evidence of progression, relapse, or death from any cause, whichever occurs first.
11. Time to response (Time Frame - 14 months):
Time from first dose of study drug to first CR, CRh, CR with incomplete blood cell recovery (CRi), CR with incomplete neutrophil recovery (CRn), CR with incomplete platelet recover (CRp), or morphologic leukemia-free state (MLFS)
12. Mortality rate (Time Frame - Up to 180 days):
rate of death from any cause within 30, 60, 90, or 180 days of first dose of study drug
13. 6-month survival rate (Time Frame - 6 months):
Probability of survival at 6 months from first dose of study drug
14. One-year survival rate (Time Frame - 1 year):
Probability of survival at 1 year from first dose of study drug
Geprüfte Regime
- Flotetuzumab (MGD006):
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
Quelle: ClinicalTrials.gov