NCT01562990

Brief Summary

The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2012

Typical duration for phase_1

Geographic Reach
2 countries

11 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

March 20, 2012

Last Update Submit

May 20, 2016

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Determination of the Recommended Dose of R-CMC544

    Determination of recommended dose will be based on safety parameters and particularly on incidence of DLTs

    Up to 16 weeks

Secondary Outcomes (5)

  • OVERALL RESPONSE RATE

    Up to 32 weeks

  • PROGRESSION-FREE SURVIVAL

    Up to 3.5 years

  • EVENT FREE SURVIVAL

    Up to 3.5 years

  • OVERALL SURVIVAL

    Up to 3.5 years

  • COMPLETE RESPONSE RATE

    30 or 32 weeks (depending on induction cycle length)

Study Arms (1)

R-CMC544 and R-GEMOX

EXPERIMENTAL

Treatment with R-CMC544 and R-GEMOX

Drug: Rituximab, CMC544, Gemcitabine and Oxaliplatine

Interventions

Rituximab, CMC544, Gemcitabine and OxaliplatineDRUG

2 cycles of induction of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43. 2 cycles of consolidation of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.

R-CMC544 and R-GEMOX

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented CD20 and CD22 positive diffuse large B-cell lymphoma, according to WHO classification. CD20 and CD22 immunophenotyping at initial diagnosis is acceptable. If such prior documentation is not available, then the immunophenotyping at relapse must be established by fine-needle aspirate or biopsy or by circulating CD20 and CD22 positive NHL cells from peripheral blood during screening. Upon registration the pathological report confirming the diagnosis, must be available
  • In first or second relapse or refractory to first and/or second line treatment. Refractory is defined as having exhibited less than or PR to a prior rituximab containing regimen or having relapsed within 6 months of the last dose of a prior rituximab containing regimen.
  • Measurable disease by bidimensional transverse CT scan assessment
  • Not eligible for autologous transplantation.
  • Previously treated with a chemotherapy regimen containing anthracyclines and rituximab.
  • Aged 18 - 80 years.
  • ECOG performance status 0 to 2.
  • Minimum life expectancy of 3 months.
  • Signed written informed consent.

You may not qualify if:

  • Burkitt, mantle cell and T-cell lymphomas.
  • Central nervous system or meningeal involvement by the lymphoma.
  • Contraindication to any drug contained in the R-GEMOX combination chemotherapy.
  • Treatment with any investigational drug within 30 days before the first planned cycle of chemotherapy and during the study.
  • Nitrosurea or mitomycin C administration within 6 weeks prior to study start.
  • Major debulking surgery within 3 weeks of treatment.
  • Any of the following lab abnormalities (unless related to the lymphoma or bone marrow infiltration):
  • Absolute neutrophil count (ANC) \< 1.500/µL (1,5.109/L).
  • Platelet count \< 100.000/µL (100.109/L).
  • Creatinin level \> 150 µmol/L (1,7 mg/dL) or 1,5 - 2,0x ULN.
  • Total bilirubin level \> 30 µmol/L (1,8 mg/dL) or 1,5x ULN.
  • Serum AST/SGOT or ALT/SGPT \>2,5x ULN.
  • Documented infection with HIV, active hepatitis B or C infection.
  • Any serious active disease or co-morbid medical condition that, according to the investigator's decision, will substantially increase the risk associated with the subject's participation in the study. Prior history of malignancies other than lymphoma with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or stage 0 (in situ) cervical carcinoma unless the subject has been disease-free for 5 or more years..
  • LVEF less than 50% (measured by echocardiography or scintigraphy).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

AZ Sint Jan

Bruges, 8000, Belgium

Location

University Hospital Gent

Ghent, 9000, Belgium

Location

CHU Mont-Godinne

Yvoir, Belgium

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon

Dijon, 21000, France

Location

CHRU de Lille

Lille, 59037, France

Location

CHU Lyon - Sud

Lyon, 69495, France

Location

CHU Hôtel Dieu

Nantes, 44093, France

Location

CHU Pontchaillou

Rennes, 35003, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

RituximabInotuzumab OzogamicinGemcitabineOxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, 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 GlobulinsGlobulinsCalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Fritz OFFNER, MD

    Lymphoma Study Association

    STUDY CHAIR

  • Corinne HAIOUN, PhD

    Lymphoma Study Association

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 26, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Study Completion

March 1, 2016

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations

BE(3)FR(8)