NCT01933711

Brief Summary

Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

14.4 years

First QC Date

August 23, 2013

Last Update Submit

May 11, 2016

Conditions

CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma

Keywords

CD20+ aggressive lymphomamantle cell lymphomarituximabmaintenance

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    Primary endpoint of the study was progression free survival (PFS)

    24 months after randomization

Secondary Outcomes (3)

  • time to progression (TTP)

    24 months after randomization

  • overall survival (OS)

    24 months after randomization

  • response to treatment

    24 months after randomization

Study Arms (2)

Rituximab maintenance

EXPERIMENTAL

maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.

Drug: rituximab

Observation

NO INTERVENTION

observational arm, no intervention

Interventions

rituximabDRUG
Rituximab maintenance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aggressive B-cell lymphoma or mantle cell lymphoma
  • CR (complete remission) oder CRu (complete remission unconfirmed) after previous therapy
  • PR (partial remission) only when PET is negative
  • minimal age 18 years
  • CD20+ expression on tumor cells
  • effective contraception
  • Karnofsky status \> 60
  • written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Heidelberg Hospital

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

University of Mannheim Hospital

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

University of Bonn Hospital

Bonn, Nordhein-Westfalen, 53127, Germany

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.Doz Dr.med.

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 2, 2013

Study Start

July 1, 2002

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

DE(3)