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Acute Lymphoblastic LeukemiaPhase 2NCT00388895

Glivec in Ph Positive Lymphoblastic Leukemia

A Phase 2 study testing chemotherapy and Glivec in people with Acute Lymphoblastic Leukemia and Cromosome Philadelphia Positive, run by PETHEMA Foundation at 28 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment Read more about this study

Who is it for?
Ages Up to 65 years
What is being tested?
chemotherapy and Glivec
How many people
35 participants
Where
28 sitesSpain
Study dates
Jun 2002to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
  • Pregnancy and women
  • Blastic crisis LMC

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Spain28 sites

  • Hospital Juan Canalejo

    A Coruña, La Coruña

  • Hospital General de Alicante

    Alicante, Alicante

  • Hospital "Duran I Reynals"

    Barcelona, Barcelona

  • Hospital "Santa Creu i Sant Pau"

    Barcelona, Barcelona

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, Barcelona

  • Hospital del Mar

    Barcelona, Barcelona

  • Hospital Germans Trias i Pujol

    Barcelona, Barcelona

  • Hospital Universitario "Germans Trias i Pujol"

    Barcelona, Barcelona

  • Hospital Valle Hebrón-Materno Infantil

    Barcelona, Barcelona

  • Hospital Valle Hebrón

    Barcelona, Barcelona

  • Hospital Puerta del Mar

    Cadiz, Cádiz

  • Fundación Jiménez Díaz

    Madrid, Madrid

  • Hospital Clínico San Carlos de Madrid

    Madrid, Madrid

  • Hospital Doce de Octubre

    Madrid, Madrid

  • Hospital Gregorio Marañón

    Madrid, Madrid

  • Hospital Ramón y Cajal

    Madrid, Madrid

  • . Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Málaga

  • Hospital Carlos Haya

    Málaga, Málaga

  • Hospital General Universitario Morales Meseguer.

    Murcia, Murcia

  • Hospital Central de Asturias

    Oviedo, Oviedo

  • Hospital Son Dureta

    Palma de Mallorca, Palma de Mallorca

  • Hospital Son Llàtzer

    Palma de Mallorca, Palma de Mallorca

  • Clínica Universitaria de Navarra

    Pamplona, Navarre

  • Hospital Clínico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla

  • Hospital Clínico de Valencia

    Valencia, Valencia

  • Hospital La Fe

    Valencia, Valencia

Other trials in Spain

About this study

Official title: Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant

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

Read the detailed description

Pilot phase II clinical trial, prospective, multicentric and opened

Being tested
chemotherapy, Glivec
Keywords
Acute lymphoblastic Leukemia
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapyDrug

  • GlivecDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2006 (estimated)
  2. Study startJun 2002
  3. Primary completionOct 2006
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388895
Sponsor's protocol ID
CSTI571BES02
Other IDs
02-0207 (nº AEMPS)
Status last verified
Nov 2008
First submitted
16 Oct 2006
Last updated
19 Nov 2008
Results posted
No

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. doi: 10.1038/sj.leu.2401973.

    PubMed 11187912

  • 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.

    PubMed 9698220

  • 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.

    PubMed 10602428

  • 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.

    PubMed 10749961

  • 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.

    PubMed 8616716

  • 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.

    PubMed 11287973

  • 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.

    PubMed 11073166

  • 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.

    PubMed 10468851

  • 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.

    PubMed 11237064

  • 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.

    PubMed 10688835

  • 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.

    PubMed 10910924

  • 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.

    PubMed 10828035

  • 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.

    PubMed 11036109

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chemotherapy and Glivec in people with Acute Lymphoblastic Leukemia and Cromosome Philadelphia Positive, run by PETHEMA Foundation at 28 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388895, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2008; AzTrials last refreshed its copy on 31 Oct 2026.

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