Glivec in Ph Positive Lymphoblastic Leukemia

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. Read our disclaimer for details. Identifier: NCT00388895
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 19, 2008
Information provided by:
PETHEMA Foundation

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

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Cromosome Philadelphia Positive Drug: chemotherapy Drug: Glivec Phase 2

Detailed Description:
Pilot phase II clinical trial, prospective, multicentric and opened

Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2002
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2007

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

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388895

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

Additional Information:

Responsible Party: Pethema, pethema Identifier: NCT00388895     History of Changes
Other Study ID Numbers: CSTI571BES02
02-0207 (nº AEMPS)
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008

Keywords provided by PETHEMA Foundation:
Acute lymphoblastic Leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action