Know Cancer

forgot password

Phase 4
15 Years
60 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia

Thank you

Trial Information

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

Improve the results of the protocol ALL-AR-03 with modifications in the study methodology of residual disease: centralized, Biomed protocols and the cut-off - <0.01% - internationally accepted and changes in the induction and consolidation treatment, without altering the overall design

Outcome Time Frame:

2 years

Safety Issue:



Spain: Ministry of Health

Study ID:




Start Date:

February 2012

Completion Date:

December 2014

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma