Glivec in Ph Positive Lymphoblastic Leukemia

NCT00388895 | Completed Phase 2

• 2 other identifiers: CSTI571BES0202-0207 (nº AEMPS)
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Acute Lymphoblastic Leukemia; Cromosome Philadelphia Positive

Keywords

Acute lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (3)

• % 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

Interventions

chemotherapy DRUG

Glivec DRUG

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (28)

Hospital General de Alicante

Alicante, Alicante, Spain

Location

Hospital "Duran I Reynals"

Barcelona, Barcelona, Spain

Location

Hospital "Santa Creu i Sant Pau"

Barcelona, Barcelona, Spain

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital del Mar

Barcelona, Barcelona, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Barcelona, Spain

Location

Hospital Universitario "Germans Trias i Pujol"

Barcelona, Barcelona, Spain

Location

Hospital Valle Hebrón-Materno Infantil

Barcelona, Barcelona, Spain

Location

Hospital Valle Hebrón

Barcelona, Barcelona, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Location

Hospital Juan Canalejo

A Coruña, La Coruña, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital General Universitario Morales Meseguer.

Murcia, Murcia, Spain

Location

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

Hospital Carlos Haya

Málaga, Málaga, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Location

Hospital Central de Asturias

Oviedo, Oviedo, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Palma de Mallorca, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Related Publications (13)

• 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. doi: 10.1038/sj.leu.2401973.

  PMID: 11187912 BACKGROUND

• 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.

  PMID: 9698220 BACKGROUND

• 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. doi: 10.1038/sj.leu.2401589.

  PMID: 10602428 BACKGROUND

• 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. doi: 10.1056/NEJM200004063421402.

  PMID: 10749961 BACKGROUND

• 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. doi: 10.1038/nm0596-561.

  PMID: 8616716 BACKGROUND

• 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. doi: 10.1056/NEJM200104053441402.

  PMID: 11287973 BACKGROUND

• 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. doi: 10.1034/j.1600-0609.2000.065004258.x.

  PMID: 11073166 BACKGROUND

• 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. doi: 10.1046/j.1365-2141.1999.01605.x.

  PMID: 10468851 BACKGROUND

• 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. doi: 10.1038/sj.leu.2402060.

  PMID: 11237064 BACKGROUND

• 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.

  PMID: 10688835 BACKGROUND

• 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.

  PMID: 10910924 BACKGROUND

• 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.

  PMID: 10828035 BACKGROUND

• 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. doi: 10.1093/jnci/92.20.1641.

  PMID: 11036109 BACKGROUND

Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Drug Therapy; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Ribera Josep Mª, Dr

  Germans Trias i Pujol Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: June 1, 2002
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2007
• Last Updated: November 19, 2008

Record last verified: 2008-11

Locations

ES (28)