Alemtuzumab and Pentostatin In T-cell Neoplasms

NCT00453193 | Terminated Phase 2 Results

• 1 other identifier: 2004-0408
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response

  Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.

  After a maximum of 6 months of therapy maintained for one month.

Study Arms (1)

Alemtuzumab + Pentostatin

EXPERIMENTAL

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

Drug: Pentostatin; Drug: Alemtuzumab

Interventions

Pentostatin DRUG

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

Also known as: Nipent®

Alemtuzumab + Pentostatin

Alemtuzumab DRUG

30 mg IV three times weekly

Also known as: Campath, CAMPATH-1

Alemtuzumab + Pentostatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Astex Pharmaceuticals, Inc.: collaborator
• Bayer: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Andersons website

MeSH Terms

Conditions

Lymphoma; Leukemia

Interventions

Pentostatin; Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Coformycin; Formycins; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Farhad Ravandi-Kashani MD/Associate Professor
• Organization: The University of Texas M D Anderson Cancer Center

eharriso@mdanderson.org

713-745-0394

Study Officials

• Farhad Ravandi-Kashani, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 28, 2007
• Study Start: September 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: March 28, 2011

Record last verified: 2012-08

Locations

US (1)