Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.
- To see how effective moxetumomab pasudotox is at destroying hairy cell leukemia tumor cells and producing lasting complete remissions.
- Individuals at least 18 years of age who have hairy cell leukemia that has not responded to or relapsed at least twice after standard therapy.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and heart and lung function tests will also be performed.
- Participants will have 28-day cycles of treatment. They will receive the study drug on days 1, 3, and 5 of every cycle. Each dose will take about 30 minutes.
- Treatment will be monitored with frequent blood and urine tests and imaging studies.
- The study will focus on the results from the first 6 months of treatment. However, participants will continue to take the study drug for as long as it is effective and the side effects are not severe.
- After stopping the study drug, participants will have frequent follow-up visits to monitor the outcome of the treatment.
Leukemia, Hairy Cell
Drug: moxetumomab pasudotox
Drug: IV Bag Protectant for Moxetumomab pasudotox
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia|
- Rate of CR in patients treated with study drug [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: every 4 weeks. ] [ Designated as safety issue: No ]
- Relapse free survival [ Time Frame: Once patients have a Complete Response (CR), they will be followed with monthly blood work for 6 months then every 3 months for 2 years, then every 6 months. Bone marrow examinations at 6 months then yearly for 2 years, then every 2 years. ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Once patients have a Complete Response (CR), Patients will be followed with monthly blood work for 6 months then every 3 months for 2 years, then every 6 months. Bone marrow examinations at 6 months then yearly for 2 years, then every 2 years. ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Patients will receive 40mcg/kg Moxetumomab Pasudotox IV over 30 minutes on days 1, 3, 5 of each 28 day cycle until CR, PD, initiation of alternate therapy or unacceptable toxicity. There is no maximum duration of therapy on this protocol.
Drug: moxetumomab pasudotox
N/ADrug: IV Bag Protectant for Moxetumomab pasudotox
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|Contact: Elizabeth J Maestri, R.N.||(301) email@example.com|
|Contact: Robert J Kreitman, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210-1240|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030-4096|
|Principal Investigator:||Robert J Kreitman, M.D.||National Cancer Institute (NCI)|