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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


Phase 2
81 Years
N/A
Open (Enrolling)
Both
Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma

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Trial Information

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


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>150┬Ámol/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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Peyrade Frederic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lymphoma Study Association

Authority:

France: ANSM - French Health Products Safety Agency

Study ID:

LNH09-7B

NCT ID:

NCT01195714

Start Date:

May 2010

Completion Date:

December 2013

Related Keywords:

  • Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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