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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01366898
Recruitment Status : Recruiting
First Posted : June 6, 2011
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
PETHEMA Foundation

June 2, 2011
June 6, 2011
March 20, 2018
May 2010
December 2018   (Final data collection date for primary outcome measure)
Efficacy in terms of response rate [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01366898 on Archive Site
  • Efficacy in terms disease free survival [ Time Frame: 5 years ]
  • Efficacy in terms of global survival [ Time Frame: 10 years ]
Same as current
Not Provided
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Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
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

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


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

Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate
Experimental: Chemotherapy
Intervention: Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate
Ribera JM, García O, Fernández-Abellán P, Lavilla E, Bernal MT, González-Campos J, Brunet S, Monteserín MC, Montesinos P, Sarrá J, Calbacho M, Alvarez-Larrán A, Tormo M, Oriol A; PETHEMA Group. Lack of negative impact of Philadelphia chromosome in older patients with acute lymphoblastic leukaemia in the thyrosine kinase inhibitor era: comparison of two prospective parallel protocols. Br J Haematol. 2012 Nov;159(4):485-8. doi: 10.1111/bjh.12043. Epub 2012 Sep 12.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Not Provided
Not Provided
PETHEMA Foundation
PETHEMA Foundation
Not Provided
Not Provided
PETHEMA Foundation
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP