PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks.

PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data

checks.

Trial Description

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.

Trial Acronym [---]*

URL of the trial [---]*

Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

Do you plan to share individual participant data with other researchers? [---]*

Description IPD sharing plan [---]*

Organizational Data

Date of Registration in DRKS: 2012/05/03

Date of Registration in Partner Registry or other Primary Registry: 2009/11/06 Investigator Sponsored/Initiated Trial (IST/IIT): no

Ethics Approval/Approval of the Ethics Committee: [---]* (leading) Ethics Committee Nr.: [---]*

EudraCT-No.

(for studies acc. to Drug Law): 2009-012476-28

Primary Registry-ID: NCT01010061 (ClinicalTrials.gov) Sponsor-ID: BO21004 (Hoffmann-La Roche)

Other Secondary-ID: 2009-012476-28; CLL1

Secondary IDs

Free text: Lymphocytic Leukemia, Chronic ICD10: C91.1 - Chronic lymphocytic leukaemia

Health condition or Problem studied

Arm 1: Drug: RO5072759 Arm 2: Drug: rituximab Arm 3: Drug: chlorambucil

Interventions/Observational Groups

Characteristics

Study Type: Interventional Study Type Non-Interventional: [---]*

Allocation: Randomized controlled trial Blinding: [---]*

Study Type: Interventional Study Type Non-Interventional: [---]*

Allocation: Randomized controlled trial Blinding: [---]*

Control: Active control (effective treament of control group) Purpose: Treatment

Assignment: Parallel Phase: III

Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Who is blinded: [---]*

- 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 Primary Outcome

Secondary Outcome

- 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

- Molecular remission: minimal residual disease (MRD); time frame: assessed after 3 cycles and 1,3,6 and 12 months after end of treatment

- 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

- Pharmacokinetics of RO5072759 in combination with Clb; time frame: pre- and post-dose sampling on day 1 of cycles 1-6

- 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

US United States AR Argentina AU Australia AT Austria BR Brazil BG Bulgaria

Countries of recruitment

CA Canada HR Croatia CZ Czech Republic DK Denmark EG Egypt EE Estonia FR France DE Germany HK Hong Kong IT Italy MX Mexico NL Netherlands NZ New Zealand RO Romania RU Russian Federation SK Slovakia ES Spain CH Switzerland TH Thailand UK United Kingdom

Locations of Recruitment

Dresden Dresden Duisburg Erlangen Erlangen Eschweiler Essen Essen Esslingen Frankfurt Frankfurt am Main Frankfurt an der Oder Frechen Freiburg Giessen Greifswald Göttingen Hamburg Hamburg Hamburg Hamburg Hamburg Hamburg Hamm Hannover Heidelberg Homburg/Saar Kaiserslautern Karlsruhe Kempten Kiel Koblenz

Koeln Kronach Köln Landshut Lebach Leer Lemgo Lörrach Lüdenscheid Magedburg Mainz Mannheim Muenchen Mutlangen München München München München Neunkirchen/Saar Nürnberg Oldenburg Porta Westfalica Ravensburg Recklinghausen Regensburg Regensburg Rostock Rüsselsheim Saarbruecken Sindelfingen Stuttgart Trier

Tübingen Ulm Villingen-Schwenningen Weilheim Wendlingen Witten Worms Wuerzburg Würzburg

Recruitment

(Anticipated or Actual) Date of First Enrollment: 2009/12/31 Target Sample Size: 786

Monocenter/Multicenter trial: Multicenter trial National/International: International

Inclusion Criteria

Gender: Both, male and female Minimum Age: 18 Years

Maximum Age: no maximum age

Additional 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

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

Hoffmann-La Roche Telephone: [---]* Fax: [---]* E-mail: [---]* Primary Sponsor URL: [---]* Clinical Trials Hoffmann-La Roche Telephone: [---]* Fax: [---]* E-mail: [---]*

Contact for Scientific Queries

URL: [---]* Clinical Trials Hoffmann-La Roche Telephone: [---]* Fax: [---]* E-mail: [---]*

Contact for Public Queries

URL: [---]*

Addresses

[---]*

Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor

Sources of Monetary or Material Support

[---]*

Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor Telephone: [---]*

Fax: [---]* E-mail: [---]* URL: [---]*

Status

Recruitment Status: Recruiting complete, follow-up continuing Study Closing (LPLV): [---]*

Trial Publications, Results and other documents

* This entry means the parameter is not applicable or has not been set.

The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs.

- Translation on version: 97

- Last processed date by ClinicalTrials.gov: 2013/10/30