CLL11: A Study of RO5072759 (GA101) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia - Full Text View

Purpose

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia. 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 (0.5mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375mg/m2 cycle 1, 500mg/m2 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.

Condition	Intervention	Phase
Lymphocytic Leukemia, Chronic	Drug: RO5072759 Drug: rituximab Drug: chlorambucil	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Chlorambucil Rituximab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate (ORR/CR/PR), duration of response and disease-free survival in CR-patients, overall survival [ 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 ] [ Designated as safety issue: No ]
Molecular remission: minimal residual disease (MRD) [ Time Frame: assessed after 3 cycles and 1,3,6 and 12 months after end of treatment ] [ Designated as safety issue: No ]
Safety profile: AEs, laboratory parameters [ Time Frame: monitored throughout study, laboratory assessments every 2 weeks on study treatment, 28 days after last dose and at intervals during follow-up ] [ Designated as safety issue: No ]
Pharmacokinetics of RO5072759 in combination with Clb [ Time Frame: pre- and post-dose sampling on day 1 of cycles 1-6 ] [ Designated as safety issue: No ]
Patient-reported outcomes and symptom burden by EORTC questionnaire [ Time Frame: after 3 cycles, 28 days after last dose and at intervals during follow-up ] [ Designated as safety issue: No ]

Enrollment:	787
Study Start Date:	December 2009
Estimated Study Completion Date:	May 2021
Estimated Primary Completion Date:	May 2021 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A (GClb)	Drug: RO5072759 1000 mg by iv infusion, on days 1, 8 and 15 in cycle 1, day 1 in cycles 2-6 (28-day cycles) Drug: chlorambucil 0,5 mg/kg orally on day 1 and 15 of each 28-day cycle
Active Comparator: B (RClb)	Drug: rituximab by iv infusion on day 1 of each 28-day cycle, 375 mg/m2 cycle 1, 500 mg/m2 cycles 2-6 Drug: chlorambucil 0,5 mg/kg orally on day 1 and 15 of each 28-day cycle
Active Comparator: C (Clb)	Drug: chlorambucil 0,5 mg/kg orally on day 1 and 15 of each 28-day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010061

Show 262 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

German CLL Study Group

Genentech

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01010061 History of Changes
Other Study ID Numbers:	BO21004, 2009-012476-28; CLL1
Study First Received:	November 6, 2009
Last Updated:	May 23, 2013
Health Authority:	Australia: National Health and Medical Research Coincil

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes

Pathologic Processes
Chlorambucil
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013