An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488162
• Other study ID #: ML25664
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: March 21, 2017
• Start date: April 4, 2011
• Est. completion date: October 24, 2016

Study information

• Verified date: March 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: October 24, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse

• Previous treatment with MabThera/Rituxan

• MabThera/Rituxan treatment planned for current relapse

Exclusion Criteria:

• Richter syndrome

• Life expectancy <6 months

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy		2 years
Secondary	Overall response rate		2 years
Secondary	Complete response rate		2 years
Secondary	Progression-free survival		2 years
Secondary	Time to next treatment		2 years
Secondary	Overall survival		2 years
Secondary	Safety (incidence of adverse events)		2 years
Secondary	Safety (incidence of hematologic adverse events)		2 years
Secondary	Safety (incidence of infections)		2 years
Secondary	Safety (incidence of secondary malignancies)		2 years