EUCTR2016-000548-33-FR
Active, Not Recruiting
Phase 1
Phase II study to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by DHAP followed by autologous transplantation plus obinutuzumab maintenance then MRD driven maintenance
YSARC0 sitesOctober 10, 2016
ConditionsMantle Cell LymphomaMedDRA version: 19.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGAZYVARO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Mantle Cell Lymphoma
- Sponsor
- YSARC
- Status
- Active, Not Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 and age \= 65
- •Histologically confirmed (according to the WHO classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14\) translocation.
- •Bone marrow aspiration performed at inclusion for MRD analyses
- •Eligible for autologous stem cell transplant
- •Previously Uuntreated MCL
- •Stage Ann Arbor II\-IV in need of treatment
- •ECOG performance status of 0 – 2
- •Life expectancy of more than 3 months
- •Written informed consent
- •Patient covered by any social security system
Exclusion Criteria
- •Severe cardiac disease: NYHA grade 3\-4
- •Impaired liver (ALAT/ASAT \= 2\.5ULN, bilirubin \= 1\.5ULN), renal (calculated creatinine clearance \< 50ml/min) or other organ function which will interfere with the treatment, if not related to lymphoma.
- •History of chronic liver disease
- •Hepatic veno\-occlusive disease or sinusoidal obstruction syndrome
- •Any of the following laboratory abnormalities, if not result of a BM infiltration:
- •\- Absolute neutrophils count (ANC) \<1,500 /mm3 (1\.5 x 109/L)
- •\- Platelet counts \< 75,000/mm3 (75 x 109/L)
- •Pregnancy/Nursing mothers
- •Fertile men or women of childbearing potential unless:
- •\- surgically sterile or \= 2 years after the onset of menopause
Outcomes
Primary Outcomes
Not specified
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