Spots Global Cancer Trial Database for Rituximab in Pretreated Elderly or Unfit B-CLL Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Rituximab in Pretreated Elderly or Unfit B-CLL Patients

Official Title: Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia

Study ID: NCT01576588

Conditions

B-Cell Chronic Lymphocytic Leukemia

Interventions

Rituximab

Glucocorticoid

Study Description

Brief Summary: The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.

Detailed Description: Patient Population: Pretreated patients with symptomatic B-CLL 18-64 years of age with poor performance status or \>/=65 years of age with any performance status. Treatment: Up-to 4 cycles of glucocorticoid (Methylprednisolone or Dexamethasone) and Rituximab every 21 day. Study Duration: The study period for each subject is expected to be 21 months. Subjects will receive up-to 4 cycles of IV infusion of Rituximab and Glucocorticoid. Maximum duration of treatment is expected to be 6 months. Subjects will complete scheduled visits not later than Study Month 21, thereafter they will enter into the long-term follow-up period. Subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival.