Multicentre study to optimize therapy of B-ALL and high grade non-Hodgkin Lymphoma in Adults - ND
- Conditions
- MedDRA version: 9.1Level: SOCClassification code 10005329Burkitt`s Lymphoma Burkitt`s Leukemia
- Registration Number
- EUCTR2009-012950-19-IT
- Lead Sponsor
- ILG (Northern Italy Leukemia Group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Burkitt`s leukemia or Burkitt`s lymphoma Age > 15 years Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy Known severe allergy to foreign proteins Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy. Pregnancy or nursing Participation in other studies that interfere with study therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in Burkitt`s leukemia or Burkitt`s lymphoma;Secondary Objective: non indicati;Primary end point(s): Remission rate Remission duration Disease free survival Overall survival
- Secondary Outcome Measures
Name Time Method