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Glivec in Ph Positive Lymphoblastic Leukemia

This study has been completed.

Sponsored by: PETHEMA Foundation
Information provided by: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00388895
  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 II

MedlinePlus related topics:   Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

ChemIDplus related topics:   Imatinib    Imatinib mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant

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)

Detailed Description:

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
Hospital Clínico Universitario de Salamanca    
      Salamanca, 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 Ramón y Cajal    
      Madrid, 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 "Duran I Reynals"    
      Barcelona, 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 Central de Asturias    
      Oviedo, Spain
. Hospital Clínico Universitario Virgen de la Victoria    
      Málaga, Spain
Hospital Carlos Haya    
      Málaga, Spain
Hospital Son Dureta    
      Palma de Mallorca, 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
Spain, Navarra
Clínica Universitaria de Navarra    
      Pamplona, Navarra, Spain
Spain, Palma de Mallorca
Hospital Son Llàtzer    
      Palma de Mallorca, Palma de Mallorca, Spain

Sponsors and Collaborators
PETHEMA Foundation

Investigators
Study Chair:     Ribera Josep Mª, Dr     Hospital Universitario "Germans Trias i Pujol"    
  More Information


Pethema Foundation web  This link exits the ClinicalTrials.gov site
 
Spanish association of Haematology  This link exits the ClinicalTrials.gov site
 

Publications:
Schrappe M, Reiter A, Zimmermann M, Harbott J, Ludwig WD, Henze G, Gadner H, Odenwald E, Riehm H. Long-term results of four consecutive trials in childhood ALL performed by the ALL-BFM study group from 1981 to 1995. Berlin-Frankfurt-Munster. Leukemia. 2000 Dec;14(12):2205-22.
 
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.
 
Snyder DS, Nademanee AP, O'Donnell MR, Parker PM, Stein AS, Margolin K, Somlo G, Molina A, Spielberger R, Kashyap A, Fung H, Slovak ML, Dagis A, Negrin RS, Amylon MD, Blume KG, Forman SJ. Long-term follow-up of 23 patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with allogeneic bone marrow transplant in first complete remission. Leukemia. 1999 Dec;13(12):2053-8.
 
Arico M, Valsecchi MG, Camitta B, Schrappe M, Chessells J, Baruchel A, Gaynon P, Silverman L, Janka-Schaub G, Kamps W, Pui CH, Masera G. Outcome of treatment in children with Philadelphia chromosome-positive acute lymphoblastic leukemia. N Engl J Med. 2000 Apr 6;342(14):998-1006.
 
Druker BJ, Tamura S, Buchdunger E, Ohno S, Segal GM, Fanning S, Zimmermann J, Lydon NB. Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat Med. 1996 May;2(5):561-6.
 
Druker BJ, Sawyers CL, Kantarjian H, Resta DJ, Reese SF, Ford JM, Capdeville R, Talpaz M. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med. 2001 Apr 5;344(14):1038-42. Erratum in: N Engl J Med 2001 Jul 19;345(3):232.
 
Saffroy R, Lemoine A, Brezillon P, Frenoy N, Delmas B, Goldschmidt E, Souleau B, Nedellec G, Debuire B. Real-time quantitation of bcr-abl transcripts in haematological malignancies. Eur J Haematol. 2000 Oct;65(4):258-66.
 
Mitterbauer G, Nemeth P, Wacha S, Cross NC, Schwarzinger I, Jaeger U, Geissler K, Greinix HT, Kalhs P, Lechner K, Mannhalter C. Quantification of minimal residual disease in patients with BCR-ABL-positive acute lymphoblastic leukaemia using quantitative competitive polymerase chain reaction. Br J Haematol. 1999 Sep;106(3):634-43.
 
Tabernero MD, Bortoluci AM, Alaejos I, Lopez-Berges MC, Rasillo A, Garcia-Sanz R, Garcia M, Sayagues JM, Gonzalez M, Mateo G, San Miguel JF, Orfao A. Adult precursor B-ALL with BCR/ABL gene rearrangements displays a unique immunophenotype based on the pattern of CD10, CD34, CD13 and CD38 expresssion. Leukemia. 2001 Mar;15(3):406-14.
 
le Coutre P, Tassi E, Varella-Garcia M, Barni R, Mologni L, Cabrita G, Marchesi E, Supino R, Gambacorti-Passerini C. Induction of resistance to the Abelson inhibitor STI571 in human leukemic cells through gene amplification. Blood. 2000 Mar 1;95(5):1758-66.
 
Mahon FX, Deininger MW, Schultheis B, Chabrol J, Reiffers J, Goldman JM, Melo JV. Selection and characterization of BCR-ABL positive cell lines with differential sensitivity to the tyrosine kinase inhibitor STI571: diverse mechanisms of resistance. Blood. 2000 Aug 1;96(3):1070-9.
 
Weisberg E, Griffin JD. Mechanism of resistance to the ABL tyrosine kinase inhibitor STI571 in BCR/ABL-transformed hematopoietic cell lines. Blood. 2000 Jun 1;95(11):3498-505.
 
Gambacorti-Passerini C, Barni R, le Coutre P, Zucchetti M, Cabrita G, Cleris L, Rossi F, Gianazza E, Brueggen J, Cozens R, Pioltelli P, Pogliani E, Corneo G, Formelli F, D'Incalci M. Role of alpha1 acid glycoprotein in the in vivo resistance of human BCR-ABL(+) leukemic cells to the abl inhibitor STI571. J Natl Cancer Inst. 2000 Oct 18;92(20):1641-50.
 

Responsible Party:   pethema ( Pethema )
Study ID Numbers:   CSTI571BES02, 02-0207 (nº AEMPS)
First Received:   October 16, 2006
Last Updated:   April 15, 2008
ClinicalTrials.gov Identifier:   NCT00388895
Health Authority:   Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute lymphoblastic Leukemia  

Study placed in the following topic categories:
Imatinib
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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