Glivec in Ph Positive Lymphoblastic Leukemia

• Sponsor: PETHEMA Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00388895
• Collaborator: (none)
• Enrollment: 35
• Locations: 28
• Duration (Months): 64
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia; Cromosome Philadelphia Positive	Drug: chemotherapy; Drug: Glivec	Phase 2

Detailed Description

Pilot phase II clinical trial, prospective, multicentric and opened

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

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

2. Discover if is possible to treat patients with Glivec plus Standard consolidation treatment. []

3. Discover the Glivec effect over ERM during consolidation treatment and alter transplant []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Clínica Universitaria de Navarra	Pamplona	Navarra	Spain
2	Hospital General de Alicante	Alicante		Spain
3	Hospital "Duran I Reynals"	Barcelona		Spain
4	Hospital "Santa Creu i Sant Pau"	Barcelona		Spain
5	Hospital Clínico y Provincial de Barcelona	Barcelona		Spain
6	Hospital del Mar	Barcelona		Spain
7	Hospital Germans Trias i Pujol	Barcelona		Spain
8	Hospital Universitario "Germans Trias i Pujol"	Barcelona		Spain
9	Hospital Valle Hebrón-Materno Infantil	Barcelona		Spain
10	Hospital Valle Hebrón	Barcelona		Spain
11	Hospital Puerta del Mar	Cádiz		Spain
12	Hospital Juan Canalejo	La Coruña		Spain
13	Fundación Jiménez Díaz	Madrid		Spain
14	Hospital Clínico San Carlos de Madrid	Madrid		Spain
15	Hospital Doce de Octubre	Madrid		Spain
16	Hospital Gregorio Marañón	Madrid		Spain
17	Hospital Ramón y Cajal	Madrid		Spain
18	Hospital General Universitario Morales Meseguer.	Murcia		Spain
19	. Hospital Clínico Universitario Virgen de la Victoria	Málaga		Spain
20	Hospital Carlos Haya	Málaga		Spain
21	Hospital Central de Asturias	Oviedo		Spain
22	Hospital Son Dureta	Palma de Mallorca		Spain
23	Hospital Son Llàtzer	Palma de Mallorca		Spain
24	Hospital Clínico Universitario de Salamanca	Salamanca		Spain
25	Hospital Universitario Marqués de Valdecilla	Santander		Spain
26	Hospital Universitario Virgen del Rocío	Sevilla		Spain
27	Hospital Clínico de Valencia	Valencia		Spain
28	Hospital La Fe	Valencia		Spain

Sponsors and Collaborators

• PETHEMA Foundation

Investigators

• Study Chair: Ribera Josep Mª, Dr, Germans Trias i Pujol Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Spanish association of Haematology

Publications

• Aricò 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, 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.
• 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.
• 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.
• 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.
• 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.
• Saffroy R, Lemoine A, Brézillon P, Frénoy 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.
• 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-Münster. Leukemia. 2000 Dec;14(12):2205-22.
• 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.
• Tabernero MD, Bortoluci AM, Alaejos I, López-Berges MC, Rasillo A, García-Sanz R, García M, Sayagués JM, González 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.
• Thomas X, Thiebaut A, Olteanu N, Danaïla 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00388895
• Other Study ID Numbers: CSTI571BES02; 02-0207 (nº AEMPS)
• First Posted: Oct 17, 2006
• Last Update Posted: Nov 19, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: Acute lymphoblastic Leukemia
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Imatinib Mesylate

Study Results

No Results Posted as of Nov 19, 2008