Status:
COMPLETED
Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Leukemia
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than once drug (combination ...
Detailed Description
OBJECTIVES: Primary * To investigate the safety and efficacy of clofarabine combined with pegaspargase in patients with high-risk acute lymphoblastic leukemia during the first phase of the study. (P...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- diagnosis after the first and before the 18th birthday AND confirmed diagnosis of acute B-precursor or or T-cell leukemia AND parents or guardians/patients give consent for inclusion in the study and transmission of data AND if none of exclusion criteria is accomplished
- Exclusion criteria:
- BCR/ABL rearrangement positive OR prior cytostatic treatment lasting \> 7 days or prior treatment with cytostatic drugs other than vincristine, daunorubicin and prednisone OR prior severe illnesses which make treatment per the protocol impossible from the outset (BUT trisomy 21 is not an exclusion criterion) OR absence of the baseline data required for assignment to a risk group in accordance with the protocol (BUT patients for whom the MRD value could not be determined for technical reasons will be treated as protocol patients) OR the disease is a secondary malignancy or relapse OR death before the start of treatment
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2024
Estimated Enrollment :
745 Patients enrolled
Trial Details
Trial ID
NCT01228331
Start Date
October 1 2010
End Date
November 20 2024
Last Update
December 11 2024
Active Locations (14)
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1
Krankenanstalten Gilead gCmbH Neurochirurgische Klinik
Bielefeld, Germany, 33617
2
Klinikum Bremen-Mitte
Bremen, Germany, D-28205
3
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, D-40225
4
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
Greifswald, Germany, 17487