Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT01540812
Eligibility Criteria:
Inclusion Criteria:
* ALL de novo high-risk criteria
* Age 15-55 years (55-60 years patients will be included at the discretion of the medical team that will attend)
* No prior treatment, except Emergency leukapheresis Emergency treatment of hyperleukocytosis with hydroxyurea Urgent cranial irradiation (one dose) for CNS leukostasis Mediastinal irradiation for urgent superior vena cava syndrome
* General condition suitable scale (ECOG 0-2), or\> 2 if due to ALL
* Negative pregnancy test for women of childbearing age
* Written informed consent because, although the protocol does not include the use of investigational drugs, biological samples sent there for them
Exclusion Criteria:
* L3 type ALL or mature phenotype B (sIg +) or cytogenetic abnormalities characteristic of mature B-ALL (t (8; 14), t (2, 8), t (8; 22)). For these patients is available BURKIMAB protocol.
* LAL Ph (BCR-ABL) positive. For these patients have the protocol ALL-Ph-08 (if under 55) or LALOPh (if over 55).
* Lymphoid blast crisis of chronic myeloid leukemia
* Biphenotypic acute leukemia or bilinear according to the criteria of EGIL group
* Undifferentiated acute leukemias
* Patients with a history of coronary artery disease, valvular or hypertensive heart disease, contraindicating the use of anthracyclines
* Patients with chronic phase of activity
* Patients with severe chronic respiratory failure
* Kidney failure due to ALL
* Serious neurological disorder not due to the LAL
* History of pancreatitis
* Pregnancy or breastfeeding
* Mental or psychiatric illness preventing informed consent is given for sending samples or properly follow the study
* General condition affected, not attributable to the ALL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
60 Years
Study:
NCT01540812
Study Brief:
Protocol Section:
NCT01540812