CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)

Completed · Phase 3

Conditions studied: Lymphocytic Leukemia, Chronic

In brief

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

Key facts

Study ID

NCT01998880

Run by

Hoffmann-La Roche

People needed

787

Starts

2009-12-22

Expected to finish

2017-08-23

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults >/=18 years
• Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
• Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
• Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min

You may not qualify if…

• Prior CLL therapy
• Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (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 ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone
• Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing
• Patients with active infection requiring systemic treatment

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Green Bay, Wisconsin, United States
• Study site — Waukesha, Wisconsin, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Argentina
• Study site — Adelaide, New South Wales, Australia
• Study site — Gosford, New South Wales, Australia
• Study site — Kogarah, New South Wales, Australia
• Study site — Liverpool, New South Wales, Australia
• Study site — St Leonards, New South Wales, Australia
• Study site — Sydney, New South Wales, Australia
• Study site — Greenslopes, Queensland, Australia
• Study site — Southport, Queensland, Australia
• Study site — Woolloongabba, Queensland, Australia
• Study site — Kurralta Park, South Australia, Australia
• Study site — Frankston, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Graz, Austria
• Study site — San Diego, California, United States

Full record on ClinicalTrials.gov

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