Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Study of Rituximab, Cladribine, and Temsirolimus in Patients With Newly Diagnosed Mantle Cell Lymphoma

Basic Trial Information

Trial Description

Purpose:

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with cladribine and rituximab and to see how well it works in treating patients with newly diagnosed mantle cell lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No CNS involvement of the cancer
• No previous therapy for mantle cell non-Hodgkin lymphoma, including radiation therapy
• No planned autologous or donor stem cell transplant
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of rituximab in week 1 and a 2-hour infusion of cladribine on 5 days in week 1. They will also receive a 30-minute infusion of temsirolimus once only, once every 2 weeks, or once every week for 3 or 4 weeks. They will also receive an injection of filgrastim for 10 days beginning in week 1 or pegfilgrastim once in week 1. Treatment may repeat every 4 weeks for up to six courses for as long as benefit is shown.

Patients will undergo blood and tissue sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

David Inwards, MD, Principal investigator		Ph: 507-284-4101

Registry Information
Official Title		Phase I/II Trial of Rituximab, Cladribine, and Temsirolimus (RCT) Therapy in Newly Diagnosed Mantle Cell Lymphoma (MCL)
Trial Start Date		2009-04-03
Registered in ClinicalTrials.gov		NCT00787969
Date Submitted to PDQ		2008-10-20
Information Last Verified		2012-02-17
NCI Grant/Contract Number		CA25224

Back to Top