Glivec in Ph Positive Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388895
First received: October 16, 2006
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Cromosome Philadelphia Positive
Drug: chemotherapy
Drug: Glivec
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
  • Discover if is possible to treat patients with Glivec plus Standard consolidation treatment.
  • Discover the Glivec effect over ERM during consolidation treatment and alter transplant

Estimated Enrollment: 35
Study Start Date: June 2002
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Pilot phase II clinical trial, prospective, multicentric and opened

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old
  • Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
  • Performance status 0-2 (Appendix B); Is allowed performance status > 2 because of LLA
  • Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine < 1,5 mg/dl o Clearance creatinine > 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV > 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
  • Negative HIV serology
  • Written, oral or with witness informed consent. In patients < 18 years old must be signed written and legal representative informed consent.
  • No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start.

Exclusion Criteria:

  • Other LLA variability
  • Previous history of coronary valvular, hypertensive cardiopathy illness
  • Chronic hepatic illness
  • Chronic respiratory insufficiency
  • Renal insufficiency not caused by LLA
  • Severe neurological problems not caused by LLA
  • Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
  • Pregnancy and women
  • Blastic crisis LMC
  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: NCT00388895

Locations
Spain
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Spain
Hospital "Santa Creu i Sant Pau"
Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain
Hospital Valle Hebrón
Barcelona, Spain
Hospital Valle Hebrón-Materno Infantil
Barcelona, Spain
Hospital "Duran I Reynals"
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Puerta del Mar
Cádiz, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital General Universitario Morales Meseguer.
Murcia, Spain
Hospital Carlos Haya
Málaga, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Dureta
Palma de Mallorca, Spain
Hospital Son Llàtzer
Palma de Mallorca, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital La Fe
Valencia, Spain
Hospital Clínico de Valencia
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Ribera Josep Mª, Dr Hospital Universitario Germans Trias i Pujol
  More Information

Additional Information:
Publications:

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00388895     History of Changes
Other Study ID Numbers: CSTI571BES02, 02-0207 (nº AEMPS)
Study First Received: October 16, 2006
Last Updated: November 17, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute lymphoblastic Leukemia

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
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014