Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by The Lymphoma Academic Research Organisation.   Recruitment status was  Recruiting

First Received on September 3, 2010.  
Last Updated on January 10, 2011  
History of Changes
This Clinical Trial Sponsored By: The Lymphoma Academic Research Organisation
Information provided by: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01195714
 

Purpose for Clinical Trial

This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4.

The anticipated study dates (start / end) are: 2010 – 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal).

Patients will be recruited over 30 months and followed at least one year after the last patient has been included.

The duration of the treatment period is approximately 20 weeks.

Condition Study Intervention Clinical Trial Phase
Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma Drug: Ofatumumab Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Ofatumumab

U.S. FDA Resources

Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures For Clinical Trial:

  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Drug: Ofatumumab

    solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles

  Eligibility

Ages Eligible for Study:   81 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.) May also be included : de Novo Transformed DLBCL from low grade lymphoma (Follicular, other…) and DLBCL associated with some small cell infiltration in bone marrow

  • Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
  • Or CD20+ Follicular lymphoma grade 3B
  • Or CD20+ Aggressive B-cell lymphoma unclassifiable Aged over 80 years. Ann Arbor stage I, II, III or IV. All aaIPI Patient non previously treated. All ECOG performance status With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV serologies test < 4 weeks (except after vaccination). Patient able to give his consent and having previously signed a written informed consent.

Patient affiliated to social security system, if applicable

Exclusion Criteria:

Any other histological type of lymphoma, Burkitt included. Any history of treated or non-treated small-B cell lymphoma. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Any serious active disease (according to the investigator’s decision). Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.

Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.

Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score <7, and a prostate specific antigen (PSA) <10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) >2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.

Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy Adult patient under tutelage.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195714

Contacts
Contact: PEYRADE Frederic, MD 04 92 03 10 22 frederic.peyrade@nice.fnclcc.fr

Locations
France
Ch Antibes Recruiting
Antibes, France, 06606
Contact: RE Daniel     04 97 24 77 46     daniel.re@ch-antibes.fr    
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33300
Contact: FITOUSSI Olivier     05 56 43 73 54     o.fitoussi@bordeauxnord.com    
Chu Cote de Nacre Recruiting
Caen, France, 14033
Contact: MACRO Margaret     02 31 27 25 39     macro-m@chu-caen.fr    
Ch Chambery Recruiting
Chambery, France, 73011
Contact: CORM Selim     04 79 96 51 05     selim.corm@gmail.com    
Ch Sud Francilien Recruiting
Corbeil Essones, France, 91106
Contact: DEVIDAS Alain     01 60 90 31 78    

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