Skip to main content
Clinical Trials/EUCTR2011-003487-75-IT
EUCTR2011-003487-75-IT
Active, not recruiting
Phase 1

Phase II trial on safety and activity of intensive short-term chemoimmunotherapy in HIV-positive patients with Burkitt's lymphoma.

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 sites19 target enrollmentDecember 23, 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Burkitt's lymphoma in HIV-positive patients.
Sponsor
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Enrollment
19
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 23, 2011
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Eligibility Criteria

Inclusion Criteria

  • 1\. Histology of Burkitt's lymphoma according to the 2008 WHO classification. 2\. HIV sero\-positivity. 3\. Age \>/\= 18 and Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 19
  • F.1\.3 Elderly (\>\=65 years) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • 1\. CNS parenchymal involvement \[patients with meningeal dissemination (lymphomatous meningosis) are eligible]. 2\. Absolute neutrophil count \< 1\.000 cells/mcL and platelets count \< 75 × 1000000000/L (Burkitt unrelated). 3\. Creatinine \> 1,5 ULN (Burkitt unrelated). 4\. SGOT and/or SGTP \> 2,5 ULN (Burkitt unrelated). 5\. Bilirubin \> 2 ULN (Burkitt unrelated). 6\. Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance. 7\. Significant cardiac disease or acute myocardial infarction in the last 12 months. 8\. Severe active infection (HBV and/or HCV co\-infection does not constitute exclusion criteria in this trial). 9\. Pregnancy or lactation.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Multinational, multicenter, phase 2 study of the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in subjects with non-infectious intermediate, posterior or pan-uveitis.non-infectious intermediate, posterior, or pan-uveitisMedDRA version: 20.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
EUCTR2020-004964-25-ITAffibody AB110
Active, not recruiting
Phase 1
Multinational, multicenter, phase 2 study of the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in subjects with non-infectious intermediate, posterior or pan-uveitis.non-infectious intermediate, posterior, or pan-uveitisMedDRA version: 20.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
EUCTR2020-004964-25-ESAffibody AB110
Active, not recruiting
Phase 1
Multinational, multicenter, phase 2 study of the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in subjects with non-infectious intermediate, posterior or pan-uveitis.non-infectious intermediate, posterior, or pan-uveitisMedDRA version: 20.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
EUCTR2020-004964-25-DEAffibody AB20
Recruiting
Not Applicable
Phase II trial on the effectiveness and safety of bariatric surgery for advanced obesityadvanced obesity
JPRN-UMIN000034438Wakayama Medical University24
Completed
Not Applicable
Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myelomaMultiple Myeloma
JPRN-UMIN000016265Sapporo Medical University Hospital30