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

October 16, 2006
October 17, 2006
November 19, 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 Archive Site
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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
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Lymphoblastic Leukemia
  • Cromosome Philadelphia Positive
  • Drug: chemotherapy
  • Drug: Glivec
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
up to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
02-0207 (nº AEMPS)
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Pethema, pethema
PETHEMA Foundation
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Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
PETHEMA Foundation
November 2008

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