Who is sponsoring NCT00496873?

NCT00496873 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT00496873?

Interventions: Cytoxan, Nipent, Rituxan.

What is the status of NCT00496873?

NCT00496873 is currently COMPLETED.

Last reviewed 2023-03-27 · How we verify

A Single-Center, Open-Label Study to Evaluate the Safety and Efficacy of Nipent, Cytoxan, and Rituxan ("PCR") in the Treatment of Previously Untreated and Treated, Stage III or IV, Low-Grade B-Cell Non-Hodgkin's Lymphoma or Bulky Lymphoma

NCT00496873 Phase 2 COMPLETED Results posted

The goal of the clinical research study is to learn if treatment with a combination of three drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or bulky lymphoma. The safety of this treatment will also be studied.

Details

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	COMPLETED
Enrolment	100
Start date	2005-06
Completion	2014-12

Conditions

Lymphoma

Interventions

Cytoxan
Nipent
Rituxan

Primary outcomes

Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 — Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months
Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.
Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy — 9 cycles of 21 days, up to 7 months
Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.

Countries

United States