Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01366898
First received: June 2, 2011
Last updated: November 19, 2013
Last verified: November 2013
  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)

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy in terms of response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: May 2014 (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
Criteria

Inclusion Criteria:

Adults over 55 years diagnosed with ALL with chromosome Ph 'negative and naïve

Exclusion Criteria:

  1. L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
  2. Biphenotypic acute leukemias and bilinear
  3. Acute undifferentiated leukemia

    The criteria for exclusion from treatment (but not patient record) any of the following:

  4. 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.
  5. General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not attributable to the LAL.
  6. LAL chromosome Ph 'positive (must register even if you follow a specific protocol).
  7. Lack of consent by the patient to use their medical records.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366898

Locations
Spain
Hospital Germans Trias i Pujol and all Hospital Pethema Recruiting
Badalona, Barcelona, Spain
Contact: José Mª Ribera, Dr       jribera@iconcologia.net   
Sponsors and Collaborators
PETHEMA Foundation
  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: November 19, 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 July 29, 2014