Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02152956|
Recruitment Status : Recruiting
First Posted : June 2, 2014
Last Update Posted : May 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|AML||Drug: Flotetuzumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)|
|Actual Study Start Date :||June 9, 2014|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
CD123 x CD3 bispecific DART® antibody
Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
Other Name: MGD006
- 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.
- 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)
- 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.
- CRh rate [ Time Frame: 14 months ]Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.
- Duration of response [ Time Frame: Up to 2 years ]Time of initial documentation of response to the time of disease relapse or death due to any cause, whichever occurs first.
- 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.
- Overall survival [ Time Frame: Up to 2 years ]Time from first dose to death from any cause
- HSCT rate [ Time Frame: 8 months ]Rate of successful hematopoietic stem cell transplantation (HSCT) through flotetuzumab treatment but before subsequent therapy.
- Incidence rate of hospitalization [ Time Frame: 8 months ]Incidence rate of hospitalization will be calculated
- Duration of hospitalization [ Time Frame: 8 months ]Duration of hospitalization will be characterized
- 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.
- 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)
- 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
- 6-month survival rate [ Time Frame: 6 months ]Probability of survival at 6 months from first dose of study drug
- One-year survival rate [ Time Frame: 1 year ]Probability of survival at 1 year from first dose of study drug
- Infusion related reaction (IRR)/cytokine release syndrome (CRS) management [ Time Frame: During study drug administration (up to 8 months) ]Determine safety and efficacy of tocilizumab in the treatment of IRR/CRS as measured by incidence of IRR/CRS
- Occurrence of dose limiting toxicity [ Time Frame: Cycle 1 of a 28 day cycle. ]Maximum Tolerated Dose/Schedule: the MTDS is defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is < 33% during the first cycle of MGD006 treatment.
- Occurrence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 9 months ]Cycle 1 through end of treatment
- Serum concentration of flotetuzumab [ Time Frame: Cycles 1 and 2 (28-day cycles) and 28 days after the last dose ]Measure the pharmacokinetics (PK) of flotetuzumab
- ADA [ Time Frame: Day 1 of Cycle 1 and Day 1 of Cycle 2 (28-day cycles) ]Occurrence of anti-drug antibody
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): NCT02152956
|Contact: Kathy Tran||trank@Macrogenics.com|
|Principal Investigator:||John DiPersio, MD, PhD||Washington University School of Medicine|
|Study Director:||Stephen L. Eck, MD, PhD||MacroGenics|
|Principal Investigator:||Norbert Vey, MD||Institute Paoli-Calmettes|