PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are
fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and,
consequently, the results of treatment are substantially lower. Additionally, elderly
patients tolerate the drugs considered relatively low-key in the management of the LAL and
suffer more toxicity. Although the LAL is much more common in patients over 60 years of age
than in younger adults, older adults with ALL are clearly underrepresented in prospective
controlled studies. A good portion of elderly patients are not able to tolerate the intensity
of the standard treatment applied to children or young adults and a significant portion of
them receive only palliative or supportive treatment. The data in the literature relating
specifically to the elderly population are scarce and most of them have obtained a
stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date,
the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients
because this protocol less aggressive than those used in high-risk ALL. However, the
development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a
relatively common type of LAL in the older patient, requires a differentiated treat these
patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol
has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a
significant benefit in survival related to the reduction of treatment (removal of the
L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a
reduction in toxicity