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10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6

10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.

mitoxantrone + etoposide + gemtuzumab ozogamicin

Redner Robert, MD

This study is an open-label, single arm phase II study which will examine the efficacy and toxicity of the combination therapy of GO, mitoxantrone and etoposide in patients who did not respond to first line induction therapy.

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.

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

Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy

The estimated percentage of patients with Complete Responses (CR / total response-evaluable patients x 100). CR in AML is defined as: 1. Normal values for absolute neutrophil count (\>1000/microL), platelet count (\>100,000/microL), independence from red cell transfusion. 2. Bone marrow biopsy reveals no clusters or collections of blast cells. Extramedullary leukemia (eg, central nervous system or soft tissue involvement) must be absent. 3. Bone marrow aspiration 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 required.

The length of time during and after the treatment that a patient lives with Acute Myeloid Leukemia that does not get worse.

The length of time from the start of treatment that patients are still alive.

Poor, Intermediate, Favorable chromosomal status.

Percent of blasts present in the bone marrow after therapy.

Pfizer

Robert Redner, MD

Professor of Medicine - Hematology/Oncology

10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6

mitoxantrone + etoposide + gemtuzumab ozogamicin: 10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.

Mitoxantrone + Etoposide + Gemtuzumab Ozogamicin

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Scoring:

0 - Fully active, able to carry on all pre-disease performance without restriction

1. - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
2. - Ambulatory and capable of all selfcare but unable to carry out any work activities; Up and about more than 50% of waking hours
3. - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4. - Completely disabled; Cannot carry out any selfcare; Totally confined to bed or chair
5. - Death

ECOG Status

Barbara M Stadterman, MPH, MSCR, CCRP

To be evaluable for clinical response, a patient must have received a total of 5 days of mitoxantrone and etoposide, received 1 dose of GO and had a follow-up bone marrow biopsy to evaluate the response to therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT03839446	Acute Myeloid L...	mitoxantrone + ...	18 Years - 75 Years	University of Pittsburgh
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	NCT03839446	Acute Myeloid L...	mitoxantrone + ...	18 Years - 75 Years	University of Pittsburgh

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