Alemtuzumab and Pentostatin In T-cell Neoplasms

This study is ongoing, but not recruiting participants.

First Received: March 26, 2007 Last Updated: August 3, 2009 History of Changes

Sponsors and Collaborators:	M.D. Anderson Cancer Center SuperGen Bayer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00453193

Purpose

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.

Condition	Intervention	Phase
Lymphoma Leukemia	Drug: Pentostatin Drug: Alemtuzumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Alemtuzumab and Pentostatin In T-Cell Neoplasms

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Pentostatin Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Objective response rate (OR= complete or partial response) [ Time Frame: After a maximum of 6 months of therapy maintained for one month. ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2004
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Alemtuzumab + Pentostatin: Experimental	Drug: Pentostatin Pentostatin 4 mg/m2 IV weekly x 4 weeks then every 2 weeks Drug: Alemtuzumab Alemtuzumab 30 mg IV three times weekly

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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-PLL, peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible.
Patients with relapsed/refractory T-PLL, T-ALL, 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 (SGPT, SGOT) less than 4 x upper limit of normal unless related to the disease.
Left ventricular ejection fraction greater than 30%.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453193

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

SuperGen

Bayer

Investigators

Principal Investigator:

Farhad Ravandi-Kashani, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Andersons website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Farhad Ravandi-Kashani M.D./Associate Professor )
Study ID Numbers:	2004-0408
Study First Received:	March 26, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00453193 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

T-Cell Neoplasms
Alemtuzumab
Pentostatin
Campath-1H

Deoxycoformycin
Lymphoma
Leukemia

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Pentostatin
Immunoproliferative Disorders

Alemtuzumab
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Pentostatin
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Pharmacologic Actions

Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Alemtuzumab
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on September 10, 2009