Overview

Alemtuzumab and Pentostatin In T-cell Neoplasms

Status:
Terminated

Trial end date:
2010-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborators:

Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Bayer

Treatments:

Alemtuzumab
Pentostatin

Criteria

Inclusion Criteria:

1. Age 18 years and older

2. Diagnosis of T lymphoid malignancy established by peripheral blood, bone marrow or
tissue (skin, lymph node or other) examination and using the standard criteria.

3. Patients with untreated T-cell-prolymphocytic leukemia (T-PLL), peripheral T-cell
lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible.

4. 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.

5. Willing to use adequate contraception for the entire duration of the study.

6. Performance status 0-2.

7. Creatinine less than or equal to 2.0 mg/dL and calculated creatinine clearance greater
than 40

8. 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.

9. Left ventricular ejection fraction greater than 30%.

Exclusion Criteria:

1. Unable or unwilling to sign the consent form.

2. Pregnant or lactating

3. Known to be HIV+

4. Active and uncontrolled infection as judged by treating physician