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An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic

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Trial Information

An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL


Inclusion Criteria:



- Adult patients, >/=18 years of age

- Patients with treatment-requiring chronic lymphocytic leukemia (CLL)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Life expectancy >6 months

Exclusion Criteria:

- Transformation to aggressive B-cell malignancy

- History of other malignancy unless the patient was treated with curative intent and
has been in remission for more than 5 years prior to enrolment

- HIV or Hepatitis B positive

- Inadequate liver or renal function

- Any coexisting medical or psychological condition that would preclude participation
in the required study procedures

Additional exclusion criterion for Part 1:

- Any previous treatment for CLL except for up to 4 cycles of rituximab iv in
combination with FC chemotherapy as first-line treatment for CLL

Additional exclusion criterion for Part 2:

Any previous treatment for CLL

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:

Part 1: C(trough) levels of subcutaneous MabThera

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agencia Espanola del Medicamento y Productos Sanitarios

Study ID:

BO25341

NCT ID:

NCT01292603

Start Date:

April 2011

Completion Date:

July 2018

Related Keywords:

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

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