Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy
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|ClinicalTrials.gov Identifier: NCT03839446|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: mitoxantrone + etoposide + gemtuzumab ozogamicin||Phase 2|
Eligible patients will be treated inpatient. Patients will receive mitoxantrone 10mg/m2 administered intravenous piggyback (IVPB) in 50ml 0.9% normal saline over 15 minutes on days 1-5 and etoposide 100 mg/m2 administered intravenously in 500 ml of 0.9% sodium chloride over 2 hours on days 1-5.
On day 6, patients will receive a single dose of GO 3mg/m2 (maximum dose 4.5mg). Patients will be pre-medicated 1 hour prior to the GO infusion with diphenhydramine 50mg administered orally or intravenously, acetaminophen 650 mg administered orally or intravenously and 1mg/kg methylprednisolone or an equivalent dose of alternative corticosteroid administered IV within 30 minutes prior to infusion of GO. GO will be administered intravenously in 50 ml (or other suitable volume resulting in a final GO concentration between 0.075 mg/mL to 0.234 mg/mL) of 0.9% sodium chloride over 2 hours. Doses of GO will be based on BSA calculated using actual body weight with a cap of 4.5mg. Vital signs will be recorded within one hour prior to the infusion and then every 30 minutes during the infusion and 30 minutes and one hour after completion of infusion. An additional dose of methylprednisolone 1 mg/kg IV may be given for any sign of infusion reaction, such as fever, chills, hypotension, or dyspnea occurring during the GO infusion or within 4 hours after the GO infusion.
For dose modifications based on kidney and liver function please see the treatment schema at the end of the study.
Supportive care including blood product transfusions, antiemetic medications, antiviral and antifungal medications, growth factor support, tumor lysis syndrome prophylaxis, or empiric antibiotics may be used at the clinical discretion of the provider.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label single arm|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy|
|Actual Study Start Date :||February 28, 2019|
|Estimated Primary Completion Date :||October 10, 2020|
|Estimated Study Completion Date :||November 10, 2023|
Experimental: mitoxantrone + etoposide + gemtuzumab ozogamicin
10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6
Drug: mitoxantrone + etoposide + gemtuzumab ozogamicin
10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
- Complete Remission Rate [ Time Frame: Up to six weeks ]
The number of patients that experience complete remission / total number of patients.
Complete Remission in AML is defined as:
1. Normal values for absolute neutrophil count (>1000/microL) and platelet count (>100,000/microL), and independence from red cell transfusion. 2. A bone marrow biopsy that reveals no clusters or collections of blast cells. Extramedullary leukemia (eg, central nervous system or soft tissue involvement) must be absent. 3. A bone marrow aspiration that reveals normal maturation of all cellular components (ie, erythrocytic, granulocytic, and megakaryocytic series). No requirement for bone marrow cellularity. 4. < 5 percent blast cells are present in the bone marrow, and none can have a leukemic phenotype (eg, Auer rods). 5. The absence of a previously detected clonal cytogenetic abnormality (ie, complete cytogenetic remission, CRc) confirms the morphologic diagnosis of CR but is not currently a required criterion.
- Progression-free Survival (PFS) [ Time Frame: Up to five years ]The length of time during and after the treatment that a patient lives with Acute Myeloid Leukemia that does not get worse.
- Overall Survival (OS) [ Time Frame: Up to five years ]The length of time from the start of treatment that patients are still alive.
- Cytogenetic Status [ Time Frame: 1 day (Determine once, at the time of AML diagnosis) ]Poor, Intermediate, Favorable chromosomal status.
- Percent of blasts [ Time Frame: 1 day (Determined once, after treatment) ]Percent of blasts present in the bone marrow after therapy.
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): NCT03839446
|Contact: Michael Boyiadzis, MDemail@example.com|
|Contact: Carrie Munizfirstname.lastname@example.org|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Michael Boyiadzis, MD 412-623-0040 email@example.com|
|Contact: Carrie Muniz, BSN 412-623-6121 firstname.lastname@example.org|
|Principal Investigator: Michael Boyiadzis, MD|