NCT01366898

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

15.4 years

First QC Date

June 2, 2011

Last Update Submit

January 17, 2022

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Efficacy in terms of response rate

    5 years

Secondary Outcomes (2)

  • Efficacy in terms disease free survival

    5 years

  • Efficacy in terms of global survival

    10 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL
Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate

Interventions

Dexamethasona, Idarubicine, ARA-C, MethotrexateDRUG
Chemotherapy

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Germans Trias i Pujol and all Hospital Pethema

Badalona, Barcelona, Spain

RECRUITING

Related Publications (1)

  • Ribera JM, Garcia O, Fernandez-Abellan P, Lavilla E, Bernal MT, Gonzalez-Campos J, Brunet S, Monteserin MC, Montesinos P, Sarra J, Calbacho M, Alvarez-Larran 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. No abstract available.

    PMID: 22966847DERIVED

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

IdarubicinCytarabineMethotrexate

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

June 30, 2007

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

ES(1)