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Brentuximab Vedotin + Chemo for AML

Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS
NCT ID: NCT01830777 (View complete trial on
DFCI Protocol ID: 13-040


This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. These trials also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. As part of this research study, patients will be administered brentuximab vedotin in combination with a conventional re-induction chemotherapy regimen called MEC, which consists of the chemotherapy drugs mitoxantrone, etoposide, and cytarabine. Brentuximab vedotin has not been approved by the FDA for the patient's cancer. However, brentuximab targets a protein on tumors called CD30, and it is approved for other cancers which express CD30, and these include Hodgkin lymphoma. This means that the FDA has not approved giving brentuximab in conjunction with MEC for use in people, including people with this type of malignancy, acute myeloid leukemia (AML). Mitoxantrone, etoposide and cytarabine are chemotherapy agents that are commonly used to treat individuals with relapsed AML. Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. Brentuximab vedotin works by using the antibody portion to enter into CD30-positive cells and then releasing the drug portion, which attempts to destroy the cell. Brentuximab vedotin has been used in laboratory and other research studies and information from those studies suggest that brentuximab vedotin may slow down the spread of cancers which express CD30. Some AML cell express CD30, so investigators hope that brentuximab vedotin will help with this type of AML. The primary purpose of this research study is to determine the highest dose that Brentuximab vedotin can safely be given with MEC without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Amir Fathi, M.D., Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion 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
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