Status:
COMPLETED
Brentuximab Vedotin + Re-induction Chemotherapy for AML
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 investig...
Detailed Description
If patients agree to participate in this research study they will be asked to undergo some screening tests or procedures to determine eligibility. Many of these tests and procedures are likely to be p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01830777
Start Date
May 1 2013
End Date
May 1 2019
Last Update
April 14 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114