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Alemtuzumab and Pentostatin In T-cell Neoplasms

NCT ID: NCT00453193

Last Updated: 2012-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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 lymphocytic leukemia and has been studied in treating patients with a number of T-cell malignancies. Alemtuzumab has been found to be effective in these conditions. Pentostatin is a drug that is approved for treating patients with hairy cell leukemia, a B-cell malignancy. Pentostatin has also been studied in a number of T-cell cancers and has been found to be effective. The purpose of this study is to see whether combining these drugs will prove to be more effective.

If you are found to be eligible to take part in this study, you will receive pentostatin through a central venous catheter in your vein once a week for 4 weeks and then every 2 weeks until the achievement of best response. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your physician will explain this procedure to you in more detail and you will be required to sign a separate consent form for this procedure.

Alemtuzumab will also be given through a vein catheter on Days 1, 2, and 3. The dose of alemtuzumab that you receive will be increased each day for the first 3 days to make sure that you tolerate it. It will then be given three times per week until you achieve the best response. If you develop reactions to alemtuzumab when given through a vein, you may receive it by injections of the same dose under the skin.

During the treatment, you will have blood (about 2 tablespoons) drawn once a week for the first 4 weeks for routine blood tests. These blood tests will then be repeated every 2 to 4 weeks for the remainder of the study. At the end of treatment a bone marrow examination will be repeated to document your response. Also, if you had a chest X-ray or CT scans, these will be repeated to confirm your level of response.

The maximum amount of time that alemtuzumab will be given is 3 months. The maximum amount of time that pentostatin will be given is 6 months. You may be able to receive the treatment will your local oncologists. However, you will have close follow-up at M. D. Anderson. You will be taken off this treatment if the disease gets worse during treatment or if unacceptable side effects develop.

You will be continued to be followed either directly or by telephone to evaluate your long-term response to treatment on this study.

This is an investigational study. Both alemtuzumab and pentostatin are commercially approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

This is an investigational study. Both alemtuzumab and pentostatin are commercially approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Conditions

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Lymphoma Leukemia

Keywords

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T-Cell Neoplasms Alemtuzumab Pentostatin Campath-1H Deoxycoformycin Lymphoma Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alemtuzumab + Pentostatin

Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks

Group Type EXPERIMENTAL

Pentostatin

Intervention Type DRUG

4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks

Alemtuzumab

Intervention Type DRUG

30 mg IV three times weekly

Interventions

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Pentostatin

4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks

Intervention Type DRUG

Alemtuzumab

30 mg IV three times weekly

Intervention Type DRUG

Other Intervention Names

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Nipent® Campath CAMPATH-1

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farhad Ravandi-Kashani, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://mdanderson.org

M.D. Andersons website

Other Identifiers

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2004-0408

Identifier Type: -

Identifier Source: org_study_id