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A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With MabThera vs no Treatment, After Induction With MabThera, Cladribine and Cyclophosphamide on Progression-free Survival in Previously Untreated Patients With Progressive B-CLL. The Trial Conducted With PALG Sites


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic

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Trial Information

A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With MabThera vs no Treatment, After Induction With MabThera, Cladribine and Cyclophosphamide on Progression-free Survival in Previously Untreated Patients With Progressive B-CLL. The Trial Conducted With PALG Sites


Inclusion Criteria:



- adult patients, 18-75 years of age;

- confirmed diagnosis of B-cell chronic lymphocytic leukemia;

- stage I-IV disease with evidence of progression;

- no previous chemotherapy, radiotherapy or immunotherapy for B-cell chronic
lymphocytic leukemia;

- ECOG PS 0-2.

Exclusion Criteria:

- active secondary malignancy or transformation to aggressive lymphoma;

- medical condition requiring chronic use of oral corticosteroids at a dose of 1mg/kg
or 60 mg/m2 over 2 weeks;

- prior treatment with interferon, MabThera or another monoclonal antibody,
immunosuppressive treatment or radiotherapy for 12 months before study start;

- history of other malignancies within 2 years before study entry, except for
adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer,
prostate cancer, or breast cancer.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival in the maintenance phase

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Poland: Ministry of Health

Study ID:

ML21283

NCT ID:

NCT00718549

Start Date:

July 2009

Completion Date:

July 2017

Related Keywords:

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

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