Burkitt`s Lymphoma Burkitt`s Leukemia MedDRA version: 9.1 Level: SOC Classification code 10005329
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: MAB
Sponsors
NILG (Northern Italy Leukemia Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed