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

October 16, 2006
November 17, 2008
June 2002
October 2006   (final data collection date for primary outcome measure)
  • % 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
Same as current
Complete list of historical versions of study NCT00388895 on ClinicalTrials.gov Archive Site
Not Provided
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Glivec in Ph Positive Lymphoblastic Leukemia
Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant

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

Pilot phase II clinical trial, prospective, multicentric and opened

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lymphoblastic Leukemia
  • Cromosome Philadelphia Positive
  • Drug: chemotherapy
  • Drug: Glivec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2007
October 2006   (final data collection date for primary outcome measure)

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
Both
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00388895
CSTI571BES02, 02-0207 (nº AEMPS)
Not Provided
Pethema, pethema
PETHEMA Foundation
Not Provided
Study Chair: Ribera Josep Mª, Dr Hospital Universitario Germans Trias i Pujol
PETHEMA Foundation
November 2008

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