Glivec in Ph Positive Lymphoblastic Leukemia

PETHEMA Foundation

Status and phase: Completed; Phase 2

Conditions: Cromosome Philadelphia Positive; Acute Lymphoblastic Leukemia

Treatments: Drug: chemotherapy; Drug: Glivec

Study type: Interventional

Funder types: Other

Identifiers

NCT00388895

CSTI571BES02

02-0207 (nº AEMPS)

Details and patient eligibility

About

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

Full description

Pilot phase II clinical trial, prospective, multicentric and opened

Sex: All

Ages: Under 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)