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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Description:

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

Outcome Time Frame:

48 months

Safety Issue:

No

Principal Investigator

Richard Greil, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Arbeitsgemeinschaft medikamentoese Tumortherapie

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

Mabtenance

NCT ID:

NCT01118234

Start Date:

December 2009

Completion Date:

December 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • Rituximab
  • Maintenance
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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