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OpenTrials
Completed

NCT Number: NCT01488162

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

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.

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Key information

Conditions

Lymphocytic Leukemia, Chronic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy

    Time frame: 2 years

Secondary outcomes

  1. Overall response rate

    Time frame: 2 years

  2. Complete response rate

    Time frame: 2 years

  3. Progression-free survival

    Time frame: 2 years

  4. Time to next treatment

    Time frame: 2 years

  5. Overall survival

    Time frame: 2 years

  6. Safety (incidence of adverse events)

    Time frame: 2 years

  7. Safety (incidence of hematologic adverse events)

    Time frame: 2 years

  8. Safety (incidence of infections)

    Time frame: 2 years

  9. Safety (incidence of secondary malignancies)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 8, 2011
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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