Comparison of three different doses of PEG-rASNase and Oncaspar in treatment of adult patients with acute lymphoblastic leukaemia
- Conditions
- Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in the bone marrow leads to suppression of normal haematopoiesis as well as disseminated infiltration of organs and release of blasts into periphal blood.MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-020613-91-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T)
2. Age >= 18 years and <= 55 years
3. Treatment according to GMALL 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL
4. Written informed consent
5. Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients or male partners during the study and at least 6 months thereafter
6. Negative pregnancy test for women of child-bearing potential
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 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patients with Philadelphia chromosome / Bcr-Abl positive ALL
2. Severe comorbidity or leukaemia-associated complications
3. Known hypersensitivity to asparaginase
4. History of severe pancreatitis
5. History of thrombosis or pulmonary embolism
6. Pre-existing clinically relevant coagulopathy
7. Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
8. Bilirubin > 1.5 x ULN
9. Other current malignancies
10. Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
11. Body mass index > 30 kg/m²
12. Known pregnancy, breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method