PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

Study Description

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Brief 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

Condition or disease	Intervention/treatment	Phase
Acute Lymphoblastic Leukemia	Drug: vINCRISTINE; Drug: Dexamethasone; Drug: Methotrexate; Drug: Cytosine arabinoside	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Treatment Protocol For All Fragile Patients Ph' Negative Over 55 Years
Study Start Date :	May 2010
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Efficacy in terms of response rate [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Efficacy in terms disease free survival [ Time Frame: 5 years ]
2. Efficacy in terms of global survival [ Time Frame: 10 years ]

Eligibility Criteria

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Ages Eligible for Study:	55 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'negative and not previously treated with frailty (> 3 points in the Charlson comorbidity index)

Exclusion Criteria:

LAL

1. L3 type mature B phenotype (sIg +) or cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]).

2 . biphenotypic acute leukemias and bilinear 3 . acute undifferentiated leukemia 4 . Patients with a Charlson comorbidity index less than or equal to 3 (and therefore that could potentially benefit from more intensive treatment PETHEMA LAL-07OLD).

5 . General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.

6 . LAL Ph 'positive (though still must register their LAL07OPH specific protocol).

7 . Lack of consent by the patient to use their clinical data

Contacts and Locations

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Contacts

Contact: Josep Mª Ribera, Dr		jmribera@iconcologia.net

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Sponsors and Collaborators

PETHEMA Foundation

More Information

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Responsible Party:	PETHEMA Foundation
ClinicalTrials.gov Identifier:	NCT01358201 History of Changes
Other Study ID Numbers:	PETHEMA LAL-07FRAIL
First Posted:	May 23, 2011
Last Update Posted:	October 26, 2017
Last Verified:	December 2016

Keywords provided by PETHEMA Foundation:

Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Methotrexate; Vincristine; Cytarabine; Anti-Inflammatory Agents; Antiemetics

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action