NCT Number: NCT00388895
Glivec in Ph Positive Lymphoblastic Leukemia
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
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Notify MeKey information
Conditions
Age range
Up to 65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Hospital General de Alicante, Alicante, Spain
About this study
Pilot phase II clinical trial, prospective, multicentric and opened
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Glivec
DrugPrimary outcomes
-
% 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
Sponsors and collaborators
Lead sponsor
PETHEMA Foundation
Other
Registry information
Official study title
Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant
Important dates
- Study start
- 2002
- Primary completion
- 2006
- Study completion
- 2007
- First posted
- Oct 17, 2006
- Registry last updated
- Nov 19, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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