Clinical trial NCT00388895: Glivec in Ph Positive Lymphoblastic Leukemia
Official title: Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Cromosome Philadelphia Positive
Keywords: Acute lymphoblastic Leukemia
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2006-10-17
Enrollment: 35
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Pilot phase II clinical trial, prospective, multicentric and opened

Eligibility criteria: 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

Primary outcomes:
measure: % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
measure: Discover if is possible to treat patients with Glivec plus Standard consolidation treatment.
measure: Discover the Glivec effect over ERM during consolidation treatment and alter transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital "Duran I Reynals"
city: Barcelona
country: Spain
facility: Hospital "Santa Creu i Sant Pau"
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitario "Germans Trias i Pujol"
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón-Materno Infantil
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer.
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Ribera Josep Mª, Dr
role: STUDY_CHAIR
References:
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citation: Thomas X, Thiebaut A, Olteanu N, Danaila C, Charrin C, Archimbaud E, Fiere D. Philadelphia chromosome positive adult acute lymphoblastic leukemia: characteristics, prognostic factors and treatment outcome. Hematol Cell Ther. 1998 Jun;40(3):119-28.
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