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An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.


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

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Trial Information

An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.


Inclusion Criteria:



- Adults >/=18 years

- Documented CD20+B-CLL

- Previously untreated CLL requiring treatment according to the NCI criteria

- Total CIRS > 6 and/or creatinine clearance < 70 ml/min

Exclusion Criteria:

- Prior CLL therapy

- Transformation of CLL to aggressive NHL (Richter's transformation)

- History of other malignancy unless the malignancy has been in remission without
treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the
cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate
cancer, or DCIS of the breast treated with lymphectomy alone

- Positive hepatitis serology (HBV, HCV) or positive HIV or HTLV testing

- Patients with active infection requiring systemic treatment

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

Outcome Time Frame:

assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Australia: National Health and Medical Research Coincil

Study ID:

BO21004

NCT ID:

NCT01010061

Start Date:

December 2009

Completion Date:

May 2021

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Baltimore, Maryland  21287
Milwaukee, Wisconsin