NCT00954005

Brief Summary

The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2003

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

8.4 years

First QC Date

August 4, 2009

Last Update Submit

August 17, 2015

Conditions

Indolent Lymphoma

Keywords

relapsed indolent lymphomagemcitabineoxaliplatinrituximab

Outcome Measures

Primary Outcomes (1)

  • Overall Remission Rate

    end of therapy

Secondary Outcomes (3)

  • Progression Free Survival

    5 years

  • Median Overall Survival

    5 years

  • Toxicity

    5 years

Study Arms (1)

Rituximab, Gemcitabine and Oxaliplatin

EXPERIMENTAL

Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle

Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin

Interventions

Therapy with Rituximab, Gemcitabine and OxaliplatinDRUG

Rituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles

Also known as: Rituximab = Mabthera, Rituxan, Gemcitabine = Gemzar, Oxaliplatin = Eloxatin
Rituximab, Gemcitabine and Oxaliplatin

Eligibility Criteria

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

You may qualify if:

  • Need for therapy in patients with relapsed/refractory patients
  • Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:
  • follicular lymphoma
  • mantle cell lymphoma
  • lymphoplasmacytic lymphoma
  • nodal or splenic marginal zone lymphoma
  • measurable disease
  • lymphoma specific therapy in the last four weeks
  • WHO performance grade 0, 1 or 2

You may not qualify if:

  • Patients suitable for high dose therapy
  • Transformation in high grade lymphoma
  • Leukocytes \< 1,5/nl or platelets \< 100/nl (except due to lymphoma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Related Publications (1)

  • Scheubeck G, Hoffmann M, Jurinovic V, Fischer L, Unterhalt M, Schmidt C, Bock HP, Duhrsen U, Kaesberger J, Kremers S, Lindemann HW, Mantovani L, Hiddemann W, Hoster E, Dreyling M; German Lymphoma Alliance (GLA). Rituximab, gemcitabine and oxaliplatin in relapsed or refractory indolent and mantle cell lymphoma: results of a multicenter phase I/II-study of the German Low Grade Lymphoma Study Group. Ann Hematol. 2024 Jul;103(7):2373-2380. doi: 10.1007/s00277-024-05689-w. Epub 2024 Mar 9.

    PMID: 38459156DERIVED

MeSH Terms

Interventions

TherapeuticsRituximabGemcitabineOxaliplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Martin Hoffmann, Dr.

    German Low Grade Lymphoma Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Martin Hoffmann, Klinikum Ludwigshafen

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

January 1, 2003

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

DE(1)