A Dose-Escalating Study of R7159 Monotherapy in Patients With CD20+ Malignant Disease. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576758

Purpose

This study will investigate the safety and tolerability of weekly intravenous R7159 monotherapy, in patients with CD20+ malignant disease. Having identified the recommended dose for further investigation, additional patients with relapsed CD20+ follicular NHL will be randomized to receive either this dose of R7159, or MabThera (rituximab) 375mg/m2, given as weekly infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: R7159 Drug: MabThera	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Dose-Escalating Study to Investigate the Safety and Tolerability of R7159 Monotherapy in Patients With CD20+ Malignant Disease

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Phase 1: Incidence of dose-limiting toxicity. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Phase 2: Overall response rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete and partial response rates, progression-free survival, event-free survival, duration of response (Phase 2 only) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters, pharmacodynamic and pharmacokinetic parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2012

Arms	Assigned Interventions
1: Experimental	Drug: R7159 iv dose for Phase 2 of study to be identified by dose-escalation in Phase 1 of study
2: Active Comparator	Drug: MabThera 375mg/m2 weekly in Phase 2 of study

Eligibility

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

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
part 1 only: CD20+ malignant disease (lymphoma or CLL);
part 2 only: relapsed CD20+ follicular non-Hodgkin's lymphoma.

Exclusion Criteria:

prior use of any investigational monoclonal antibody within 6 months of study start;
prior use of any anti-cancer vaccine;
prior use of MabThera within 8 weeks of study entry;
CNS lymphoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576758

Contacts

Contact: Please reference Study ID Number: BO21003	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Austria
	Not yet recruiting
Salzburg, Austria, 5020
Canada, Alberta
	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
	Recruiting
VANCOUVER, British Columbia, Canada, V5Z 4E6
Canada, Ontario
	Not yet recruiting
KINGSTON, Ontario, Canada, K7L 5P9
	Not yet recruiting
TORONTO, Ontario, Canada, M4N 3M5
	Recruiting
LONDON, Ontario, Canada, N6A 4G5
	Recruiting
TORONTO, Ontario, Canada, M5G 2M9
Canada, Quebec
	Recruiting
MONTREAL, Quebec, Canada, H3T 1E2
Italy
	Not yet recruiting
MILANO, Italy, 20141
	Not yet recruiting
PISA, Italy, 56100
	Not yet recruiting
TORINO, Italy, 10126
	Not yet recruiting
BRESCIA, Italy, 25123
	Not yet recruiting
NOVARA, Italy, 28100
Poland
	Not yet recruiting
WARSZAWA, Poland, 02-781
	Not yet recruiting
WARSZAWA, Poland, 02-097

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO21003
Study First Received:	December 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00576758
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009