PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
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ClinicalTrials.gov Identifier: NCT01358201 |
Recruitment Status
:
Recruiting
First Posted
: May 23, 2011
Last Update Posted
: October 26, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia | Drug: vINCRISTINE Drug: Dexamethasone Drug: Methotrexate Drug: Cytosine arabinoside | Phase 4 |

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 |
- Efficacy in terms of response rate [ Time Frame: 5 years ]
- Efficacy in terms disease free survival [ Time Frame: 5 years ]
- Efficacy in terms of global survival [ Time Frame: 10 years ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358201
Contact: Josep Mª Ribera, Dr | jmribera@iconcologia.net |

Responsible Party: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT01358201 History of Changes |
Other Study ID Numbers: |
PETHEMA LAL-07FRAIL |
First Posted: | May 23, 2011 Key Record Dates |
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 |