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Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Diffuse Large B Cell Lymphoma CD20+

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Trial Information

Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI


Inclusion Criteria:



- Histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification)

- Baseline PET scan available with at least one hypermetabolic lesion

- Aged ≥ 18 years and ≤ 60 years

- Eligible for autologous stem cell transplant

- Patient not previously treated

- Age adjusted International Prognostic Index (aa-IPI) equal to 1, 2 or 3

- Life expectancy ≥ 3 months

- Negative HIV, HBV (anti-HBc negativity) and HCV serologies before inclusion

- Having signed a written informed consent

- Having ability and willingness to comply with study protocol procedures

- Men must agree to use a barrier method of contraception during the treatment period
and until 3 months after the last dose of GA101 or rituximab, or ACVBP14 or CHOP14
chemotherapy, whichever is longer

- Women of childbearing potential must agree to use an adequate method of
contraception, such as oral contraceptives, intrauterine device, or barrier method of
contraception during the treatment period and until 12 months after the last dose of
GA101, Rituximab, ACVBP14, or CHOP14 chemotherapy, whichever is longer

Exclusion Criteria:

- Any other histological type of lymphoma

- Any history of treated or non-treated indolent lymphoma. However, patients not
previously diagnosed and having a diffuse large B-cell lymphoma with some small cell
infiltration in bone marrow or lymph node may be included

- Central nervous system or meningeal involvement by lymphoma

- Contra-indication to any drug contained in the chemotherapy regimens

- Poor cardiac function (LVEF < 50%) on echocardiogram or MUGA scan

- Poor renal function (creatinine level > 150*mol/l or clearance < 30ml/min), poor
hepatic function (total bilirubin level > 30µmol/l, transaminases > 2.5 X 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

- Any serious active disease (according to the investigator's decision)

- Treatment with any investigational drug within 30 days before planned first cycle of
chemotherapy

- Pregnant or lactating women

- Adult patient under tutelage

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year Event Free Survival

Outcome Description:

EFS is defined as PET positivity according to ΔSUVmax criteria after 2 or 4 induction cycles as defined by RAC (based on central PET review), progression or relapse according to Cheson 2007, modification of planned treatment out of progression or death of any cause.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Olivier Casasnovas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lymphoma Study Association

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

GAINED

NCT ID:

NCT01659099

Start Date:

September 2012

Completion Date:

February 2019

Related Keywords:

  • Diffuse Large B Cell Lymphoma CD20+
  • DLBCL
  • aa-IPI > or equal to 1
  • Diagnosis
  • 18 to 60 years
  • Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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