Who is sponsoring NCT00472056?

NCT00472056 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT00472056?

Interventions: Carmustine, Etoposide, Cytarabine, Melphalan, Rituximab.

What is the status of NCT00472056?

NCT00472056 is currently COMPLETED.

Last reviewed 2016-02-17 · How we verify

Randomized Trial Using Standard Dose Versus High Dose Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Diffuse Large B Cell Lymphomas

NCT00472056 Phase 2 COMPLETED Results posted

Cohort 1: Patients who are less than or equal to 65 years of age. 1\. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) Cohort 2: Patients who are older than 65 years of age 1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) 2. To determine the treatment related mortality (TRM)

Details

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	COMPLETED
Enrolment	93
Start date	2005-03
Completion	2012-06

Conditions

Lymphoma

Interventions

Carmustine
Etoposide
Cytarabine
Melphalan
Rituximab

Primary outcomes

Disease-free Survival (DFS) — Up to 5 years from transplant date.
DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.

Countries

United States