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Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant


Phase 2
N/A
65 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia, Cromosome Philadelphia Positive

Thank you

Trial Information

Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant


Pilot phase II clinical trial, prospective, multicentric and opened


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Ribera Josep Mª, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Universitario Germans Trias i Pujol

Authority:

Spain: Ministry of Health

Study ID:

CSTI571BES02

NCT ID:

NCT00388895

Start Date:

June 2002

Completion Date:

October 2007

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Cromosome Philadelphia Positive
  • Acute lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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