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Protocol No.1564GCCPrincipal InvestigatorEmadi, Ashkan
PhasePhase I
Age GroupAdult
TitlePhase I trial of brentuximab vedotin combined with re-induction chemotherapy in patients with relapsed or refractory, CD30-expressing acute myeloid leukemia (AML).
DescriptionTo start re-induction therapy, patients will receive brentuximab vedotin alone on Day 1. They will begin treatment with MEC (mitoxantrone, etoposide and cytarabine) a few days later (on Day 3). Since investigators are looking for the highest dose at which brentuximab vedotin can be safely administered with MEC without severe or unmanageable side effects in those with AML, not everyone who participates in this research study will receive the same dose of the study drug. The dose a patient receives will depend on the number of participants who have been enrolled in the study before that patient and how well they have tolerated their doses.

For this study, treatment will be broken up into segments. Study treatment will occur in two segments: 1) Re-Induction Therapy; and 2) Maintenance Therapy. Re-induction therapy, as described above, will be the combination of brentuximab vedotin followed on day 3 by MEC chemotherapy. The maintenance phase of therapy will only include brentuximab vedotin administered every 21 days for a total period of 12 months, and does not include any other chemotherapy. The treatment and assessments that may be required fo patients during these phases of therapy are explained below. The following assessments will be completed while patients are on the trial: physical exam, performance status, urine test, blood tests and bone marrow aspirate/biopsy.

The first part of the study treatment is called "re-induction". During re-induction, patients will be admitted to the Massachusetts General Hospital and will receive study treatment on an in-patient basis. Patients will receive brentuximab vedotin IV (intravenously or through a vein) alone on Day 1. They will then receive the following standard drugs (the MEC regimen) starting on day 3. This regimen includes the chemotherapy drugs mitoxantrone, etoposide, and cytarabine, all given by IV and beginning on Day 3 and continuing through Day 7.

If at the end of the re-induction course, the number of leukemia cells have not decreased as much as expected or desired, patients will be removed from the study and given alternative options.

The second part of study treatment is called "maintenance" and can be given on an outpatient basis in clinic. During maintenance, patients will be administered brentuximab vedotin once every 21 days, at the same dose as that given during the re-induction course. This 21 day period will be called a cycle, and will be repeated until 12 months have passed from the start of the maintenance therapy phase. During this phase, participants will not receive other chemotherapies and will not be hospitalized for treatment. During the maintenance phase, investigators will continue to collect approximately 2 to 3 teaspoons of blood for research purposes every 3-4 weeks.

Investigators would like to keep track of patients' medical condition and overall health following the 12 months of treatment on study. Investigators may ask patients questions about their general health, current medications and disease status. Investigators will also check on any new anticancer therapy patients may have started.
TreatmentExperimental: Experimental Arm Brentuximab Vedotin + MEC Drug: Brentuximab Vedotin Intravenously on Day 1 during re-induction therapy. Intravenously every 21 days during maintenance therapy Drug: Mitoxantrone Intravenously on Days 3-7 of re-induction therapy. Drug: Etoposide Intravenously on Days 3-7 of re-induction therapy. Drug: Cytarabine Intravenously on Days 3-7 of re-induction therapy.
Key EligibilityInclusion criteria:
-Pathologically confirmed, relapsed acute myelogenous leukemia following a remission duration of at least 3 months
-CD30 expressing AML
-Willing to use acceptable method of contraception

Exclusion criteria:
-Have received systemic antineoplastic therapy, including radiotherapy within 14 days of study treatment
-Pregnant or breastfeeding
-Diagnosis of acute promyelocytic leukemia
-Refractory acute myeloid leukemia
-History of a different malignancy except if disease free for at least 5 years and at low risk of remission or one of the following within the past 5 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin
-Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
-Uncontrolled intercurrent illness
-HIV positive on combination antiretroviral therapy
-Diagnosis of active hepatitis B or C
-Current or history of congestive heart failure NYHA class 3 or 4
-Current or history of ventricular or life-threatening arrythmias or diagnosis of long-QT syndrome
-Systemic infection requiring IV antibiotic therapy within 7 days before first dose of study drug

For detailed criteria, please call study site contact(s) for more information.
Applicable Disease SitesAcute Myeloid Leukemia
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Therapy (NOS)
Drugs InvolvedCytarabine (Cytosine Arabinoside)
Mitoxantrone
VP-16 (etoposide)
brentuximab vedotin
etoposide
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT01830777
ContactGreenebaum Cancer Center Patricia Lesho Phone:410-328-2577
Pager:410-328-2337 #1831
Email:plesho@umm.edu
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