Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
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Purpose
The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years) |
- Efficacy in terms of response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Efficacy in terms disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Efficacy in terms of global survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Chemotherapy | Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate |
Detailed Description:
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml/day, allopurinol 300 mg / day, gastric protection (as center), daily monitoring of blood glucose, daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge.
Remission induction:
Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. The total duration of the induction is 30 days, consists of two phases (Phase I, days +1 to +14 and phase II, days +15 to +30). Mandatory testing is considered counting the percentage of blasts in peripheral blood +8 day of induction, a myelogram to day +14 to assess early response and a day +35 to assess the complete remission
(days +1 to +14)
- Vincristine (VCR) 1 mg (absolute dose) IV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) IV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 IV, 8 to 11
days +15 to +30)
- cyclophosphamide (CFM): 300 mg / m 2 iV in 1 hour 15 to 17. (3 total doses).
- Cytarabine (ARAC): 60 mg / m 2 iV in 1 hour 16 to 19, 23 to 26. (8 total doses).
- Vincristine (VCR) 1 mg (absolute dose) iV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) iV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 iV, 8 to 11
Consolidation:
Cycles 1, 3, 5 MTX: 1,000 mg/m2, IV infusion of 24 hours day 1 L-ASA. 10,000 IU / m 2 IV or IM Day 2 Cycles 2, 4, 6 ARAC: 1,000 mg/m2, IV in 3 hours on days 1, 3 and 5
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adults over 55 years diagnosed with ALL with chromosome Ph 'negative and naïve
Exclusion Criteria:
- L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
- Biphenotypic acute leukemias and bilinear
Acute undifferentiated leukemia
The criteria for exclusion from treatment (but not patient record) any of the following:
Patients with a history of severe and uncontrolled disease, including:
- Coronary artery disease, valvular or hypertensive heart disease.
- Chronic liver disease (active viral or alcoholic).
- Chronic respiratory failure.
- Renal failure not due to the ALL.
- Serious neurological disorder not due to the ALL. f. Improperly controlled diabetes.
- General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not attributable to the LAL.
- LAL chromosome Ph 'positive (must register even if you follow a specific protocol).
- Lack of consent by the patient to use their medical records.
Contacts and Locations| Spain | |
| Hospital Germans Trias i Pujol and all Hospital Pethema | Recruiting |
| Badalona, Barcelona, Spain | |
| Contact: José Mª Ribera, Dr jribera@iconcologia.net | |
More Information
No publications provided by PETHEMA Foundation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | PETHEMA Foundation |
| ClinicalTrials.gov Identifier: | NCT01366898 History of Changes |
| Other Study ID Numbers: | LAL-07OLD |
| Study First Received: | June 2, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013