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Completed

NCT Number: NCT01118234

Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

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Key information

Conditions

Chronic Lymphocytic Leukemia 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

Interventional

Phase

Phase 3

Primary location

Landesklinikum Krems, Hämato-onkologisches Service, Krems, Lower Austria, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • B-CLL
  • Age >18
  • ECOG performance status 0-2
  • Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
  • Patient must be in complete remission or partial remission after an induction treatment containing rituximab
  • ANC (absolute neutrophil count) > 1,0 x 10e9 /L
  • Life expectancy > 6 months
  • Patient´s written informed consent
  • Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter

Exclusion criteria

  • Active uncontrolled bacterial, viral or fungal infection
  • Significantly reduced organ functions and bone marrow dysfunction not due to CLL
  • creatinine clearance of below 30mL/min
  • Patients with a history of other malignancies within 2 years prior to study entry
  • Patients with a history of severe cardiac disease
  • Other known comorbidity with the potential to dominate survival
  • Transformation to aggressive B-cell malignancy
  • Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
  • Medical condition requiring prolonged (> 1 month) use of oral corticosteroids
  • Pregnant or breast feeding women
  • Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Treatment and study plan

Rituximab

Drug

Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation

Primary outcomes

  1. progression free survival

    Time frame: 48 months

    Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease.

Secondary outcomes

  1. MRD (minimal residual disease) progression free survival

    Time frame: 48 months

    Minimal residual disease progression-free survival is defined as the period from randomization until increase of MRD levels in peripheral blood above 10-3 or, if above 10-3 before, increase of one common logarithm.

  2. conversion rate to MRD negative

    Time frame: 48 months

  3. median MRD levels

    Time frame: 48 months

  4. conversation rate to CR

    Time frame: 48 months

  5. effect of MRD levels on clinical PFS and OS

    Time frame: 48 months

  6. event free survival

    Time frame: 48 months

  7. time to next treatment

    Time frame: 48 months

  8. overall survival

    Time frame: 48 months

  9. Safety of Rituximab maintenance treatment in patients with CLL

    Time frame: 48 months

    All grades of infections and G3/4 other clinical adverse events will be documented using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

  10. benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia

Important dates

Study start
2009
Primary completion
2018
Study completion
2019
First posted
May 6, 2010
Registry last updated
Jan 9, 2020

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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