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A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)

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Roche

Status and phase

Completed
Phase 2
Phase 1

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Ocrelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02723071
BO18414
2004-004110-17 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Follicular NHL
  • Documented history of response, or stable disease more than 6 months in duration, to a rituximab-containing regimen that was the last treatment before enrollment in the study
  • No evidence of hepatitis B or C

Exclusion criteria

  • Prior monoclonal antibody therapy other than rituximab, anti-cancer vaccine, or radioimmunotherapy for cancer
  • History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
  • Major nondiagnostic surgery within 4 weeks of Screening

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 3 patient groups

Cohort A: Ocrelizumab 200 mg/m^2
Experimental group
Description:
Participants will receive a total of 8 infusions of ocrelizumab 200 milligram per square meter (mg/m\^2) given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Treatment:
Drug: Ocrelizumab
Cohort B: Ocrelizumab 375 mg/m^2
Experimental group
Description:
Participants will receive a total of 8 infusions of ocrelizumab 375 mg/m\^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Treatment:
Drug: Ocrelizumab
Cohort C: Ocrelizumab 375/750 mg/m^2
Experimental group
Description:
Participants will receive first infusion of ocrelizumab 375 mg/m\^2 followed by 7 infusions of 750 mg/m\^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Treatment:
Drug: Ocrelizumab

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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