Alemtuzumab and Pentostatin In T-cell Neoplasms

Stopped early · Phase 2

Conditions studied: Lymphoma, Leukemia

In brief

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.

Key facts

Study ID

NCT00453193

Run by

M.D. Anderson Cancer Center

People needed

26

Starts

2004-09-01

Expected to finish

2010-03-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• Unable or unwilling to sign the consent form.
• Pregnant or lactating
• Known to be HIV+
• Active and uncontrolled infection as judged by treating physician

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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