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Glivec in Ph Positive Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia, Cromosome Philadelphia Positive

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
chemotherapy
Glivec
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute lymphoblastic Leukemia

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clínica Universitaria de Navarra
  • Hospital General de Alicante
  • Hospital "Duran I Reynals"
  • Hospital "Santa Creu i Sant Pau"
  • Hospital Clínico y Provincial de Barcelona
  • Hospital del Mar
  • Hospital Germans Trias i Pujol
  • Hospital Universitario "Germans Trias i Pujol"
  • Hospital Valle Hebrón-Materno Infantil
  • Hospital Valle Hebrón
  • Hospital Puerta del Mar
  • Hospital Juan Canalejo
  • Fundación Jiménez Díaz
  • Hospital Clínico San Carlos de Madrid
  • Hospital Doce de Octubre
  • Hospital Gregorio Marañón
  • Hospital Ramón y Cajal
  • Hospital General Universitario Morales Meseguer.
  • . Hospital Clínico Universitario Virgen de la Victoria
  • Hospital Carlos Haya
  • Hospital Central de Asturias
  • Hospital Son Dureta
  • Hospital Son Llàtzer
  • Hospital Clínico Universitario de Salamanca
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Virgen del Rocío
  • Hospital Clínico de Valencia
  • Hospital La Fe

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 16, 2006
Last Updated
November 17, 2008
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00388895
Brief Title
Glivec in Ph Positive Lymphoblastic Leukemia
Official Title
Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PETHEMA Foundation

4. Oversight

5. Study Description

Brief Summary
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
Detailed Description
Pilot phase II clinical trial, prospective, multicentric and opened

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Cromosome Philadelphia Positive
Keywords
Acute lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
Glivec
Primary Outcome Measure Information:
Title
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
Title
Discover if is possible to treat patients with Glivec plus Standard consolidation treatment.
Title
Discover the Glivec effect over ERM during consolidation treatment and alter transplant

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ribera Josep Mª, Dr
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital "Duran I Reynals"
City
Barcelona
Country
Spain
Facility Name
Hospital "Santa Creu i Sant Pau"
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario "Germans Trias i Pujol"
City
Barcelona
Country
Spain
Facility Name
Hospital Valle Hebrón-Materno Infantil
City
Barcelona
Country
Spain
Facility Name
Hospital Valle Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos de Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer.
City
Murcia
Country
Spain
Facility Name
. Hospital Clínico Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Carlos Haya
City
Málaga
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
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Citation
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Citation
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Citation
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Results Reference
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology

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Glivec in Ph Positive Lymphoblastic Leukemia

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