Glivec in Ph Positive Lymphoblastic Leukemia
This study has been completed.
Sponsor:
PETHEMA Foundation
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388895
First received: October 16, 2006
Last updated: November 17, 2008
Last verified: November 2008
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Purpose
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia Cromosome Philadelphia Positive |
Drug: chemotherapy Drug: Glivec |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant |
Resource links provided by NLM:
Further study details as provided by PETHEMA Foundation:
Primary Outcome Measures:
- % 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
| Estimated Enrollment: | 35 |
| Study Start Date: | June 2002 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Pilot phase II clinical trial, prospective, multicentric and opened
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388895
Locations
| Spain | |
| Clínica Universitaria de Navarra | |
| Pamplona, Navarra, Spain | |
| Hospital General de Alicante | |
| Alicante, Spain | |
| Hospital Universitario "Germans Trias i Pujol" | |
| Barcelona, Spain | |
| Hospital "Santa Creu i Sant Pau" | |
| Barcelona, Spain | |
| Hospital Clínico y Provincial de Barcelona | |
| Barcelona, Spain | |
| Hospital Valle Hebrón | |
| Barcelona, Spain | |
| Hospital Valle Hebrón-Materno Infantil | |
| Barcelona, Spain | |
| Hospital "Duran I Reynals" | |
| Barcelona, Spain | |
| Hospital del Mar | |
| Barcelona, Spain | |
| Hospital Germans Trias i Pujol | |
| Barcelona, Spain | |
| Hospital Puerta del Mar | |
| Cádiz, Spain | |
| Hospital Juan Canalejo | |
| La Coruña, Spain | |
| Hospital Clínico San Carlos de Madrid | |
| Madrid, Spain | |
| Hospital Ramón y Cajal | |
| Madrid, Spain | |
| Hospital Doce de Octubre | |
| Madrid, Spain | |
| Hospital Gregorio Marañón | |
| Madrid, Spain | |
| Fundación Jiménez Díaz | |
| Madrid, Spain | |
| Hospital General Universitario Morales Meseguer. | |
| Murcia, Spain | |
| Hospital Carlos Haya | |
| Málaga, Spain | |
| . Hospital Clínico Universitario Virgen de la Victoria | |
| Málaga, Spain | |
| Hospital Central de Asturias | |
| Oviedo, Spain | |
| Hospital Son Dureta | |
| Palma de Mallorca, Spain | |
| Hospital Son Llàtzer | |
| Palma de Mallorca, Spain | |
| Hospital Clínico Universitario de Salamanca | |
| Salamanca, Spain | |
| Hospital Universitario Marqués de Valdecilla | |
| Santander, Spain | |
| Hospital Universitario Virgen del Rocío | |
| Sevilla, Spain | |
| Hospital La Fe | |
| Valencia, Spain | |
| Hospital Clínico de Valencia | |
| Valencia, Spain | |
Sponsors and Collaborators
PETHEMA Foundation
Investigators
| Study Chair: | Ribera Josep Mª, Dr | Hospital Universitario Germans Trias i Pujol |
More Information
Additional Information:
Publications:
| Responsible Party: | Pethema, pethema |
| ClinicalTrials.gov Identifier: | NCT00388895 History of Changes |
| Other Study ID Numbers: | CSTI571BES02, 02-0207 (nº AEMPS) |
| Study First Received: | October 16, 2006 |
| Last Updated: | November 17, 2008 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by PETHEMA Foundation:
|
Acute lymphoblastic Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013