A Study of MabThera/Rituxan (Rituximab) in Patients With... | NCT01388959

Studies
A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

NCT01388959

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Interventions

rituximab [MabThera/Rituxan]

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1998

Primary Completion Date

Apr 2004Actual

Completion Date

Apr 2004Actual

First Submitted Date

Jul 5, 2011

First Submission Date that Met QC Criteria

Jul 5, 2011

First Posted Date

Jul 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Experimental		Drug: rituximab [MabThera/Rituxan]

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rituximab [MabThera/Rituxan]	Drug	375 mg/m2 intravenously once a week for 4 weeks	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment response rate according to World Health Organization criteria (Group A)		Day 50
Normalization of B-cell lymphoma 2 levels		Day 50

Secondary Outcomes

Measure	Description	Time Frame
Safety: Incidence of adverse events		3 years
Progression-free survival		3 years
Duration of treatment response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, 18-75 years of age
Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)

Exclusion Criteria:

Active viral hepatitis
Eastern Cooperative Oncology Group (ECOG) performance status >2
Patients not willing to sign informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069283	Rituximab

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided