Status:
TERMINATED
Alemtuzumab and Pentostatin In T-cell Neoplasms
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Astex Pharmaceuticals, Inc.
Bayer
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab can help to control T-cell malignancy. The safety of this combination therapy will also be studied.
Detailed Description
Alemtuzumab is an antibody protein that is directed towards a marker molecule on the surface of both B- and T- lymphoid cells. It is currently approved for use in treating patients with chronic lympho...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Diagnosis of T lymphoid malignancy established by peripheral blood, bone marrow or tissue (skin, lymph node or other) examination and using the standard criteria.
- Patients with untreated T-cell-prolymphocytic leukemia (T-PLL), peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible.
- Patients with relapsed/refractory T-PLL, T-lineage acute lymphoblastic leukemia (T-ALL), Adult T-cell leukemia/lymphoma (ATLL), peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma and other T-lymphoid malignancies are eligible. Patients who have had prior therapy with either alemtuzumab or pentostatin as single agents are eligible.
- Willing to use adequate contraception for the entire duration of the study.
- Performance status 0-2.
- Creatinine less than or equal to 2.0 mg/dL and calculated creatinine clearance greater than 40
- Bilirubin less than or equal to 3.0 mg/dL, transaminases (aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT)) less than 4 x upper limit of normal unless related to the disease.
- Left ventricular ejection fraction greater than 30%.
Exclusion
- Unable or unwilling to sign the consent form.
- Pregnant or lactating
- Known to be HIV+
- Active and uncontrolled infection as judged by treating physician
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00453193
Start Date
September 1 2004
End Date
March 1 2010
Last Update
August 7 2012
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030