Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

NCT00458848 | Completed Phase 2 Results

• 2 other identifiers: LAL09042004-001738-11
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 66

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Conditions

Leukemia

Keywords

B-cell adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; TdT positive adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reaching Disease Free Survival

  At 60 months

Secondary Outcomes (2)

• Number of Patients Reaching Complete Hematological Response After Induction Therapy

  At the end of induction, day +50

• Percentage of Participants Reaching Overall Survival

  At 60 months

Interventions

asparaginase DRUG

daunorubicin hydrochloride DRUG

etoposide DRUG

idarubicin DRUG

imatinib mesylate DRUG

mercaptopurine DRUG

methotrexate DRUG

methylprednisolone DRUG

mitoxantrone hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

allogeneic hematopoietic stem cell transplantation PROCEDURE

autologous hematopoietic stem cell transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria: * Negative myeloperoxidase stain * Phenotype T (T-ALL) or B (B-ALL) * No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative) PATIENT CHARACTERISTICS: * Creatinine ≤ 2.5 mg/dL (after adequate hydration) * SGOT and SGPT ≤ 3 times upper limit of normal * LVEF ≥ 50% * No severe psychiatric disorders * No other concurrent malignant disease * No presence of documented infections not responding to antibiotic and/or antifungal therapy * Not pregnant PRIOR CONCURRENT THERAPY: * No prior steroids * No prior antiblastic chemotherapy * No other concurrent chemotherapy or radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (66)

Ospedale Civile Alessandria

Alessandria, I-15100, Italy

Location

Ospedale Torrette University Ancona

Ancona, 60020, Italy

Location

Ospedale S. Donato

Arezzo, 52100, Italy

Location

Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"

Ascoli Piceno, Italy

Location

S.G. Moscati Hospital

Avellino, 83100, Italy

Location

Universita Degli Studi di Bari

Bari, 70124, Italy

Location

University of Bologna Medical School

Bologna, 40138, Italy

Location

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

A. Perrino Hospital

Brindisi, 72100, Italy

Location

Ospedale Binaghi

Cagliari, 090100, Italy

Location

Ospedale Ferrarotto

Catania, 95124, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza

Cosenza, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Azienda Ospedaliera di Firenze

Florence, 50011, Italy

Location

Ospedali Riuniti Foggia

Foggia, 71100, Italy

Location

Ospedale Umberto I

Frosinone, 03100, Italy

Location

Ospedale S. Antonio Abate

Gallarate, 21013, Italy

Location

Ospedale San Martino

Genoa, 16132, Italy

Location

Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Lecce, Italy

Location

Ospedale Maggiore Lodi

Lodi, I-20075, Italy

Location

Ospedale L'Aquila

L’Aquila, 67100, Italy

Location

Azienda Ospedaliera Universitaria - Policlinico G. Martino

Messina, 98125, Italy

Location

Ospedale Niguarda Ca'Granda

Milan, 20162, Italy

Location

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

Naples, 80127, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Ospedale S. Gennaro ASL NA1

Naples, 80131, Italy

Location

Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I

Nocera Inferiore, Italy

Location

Amedeo Avogadro University of Eastern Piedmont

Novara, I-28100, Italy

Location

Ospedale San Francesco

Nuoro, 08100, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, 10043, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Policlinico - Cattedra di Ematologia

Palermo, 90100, Italy

Location

Ospedale Cervello

Palermo, 90146, Italy

Location

Ospedale La Maddalena - Palermo

Palermo, Italy

Location

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

University of Pavia

Pavia, 27100, Italy

Location

Perugia Regional Cancer Center

Perugia, 06122, Italy

Location

Azienda Ospedale - d S. Salvatore

Pesaro, 61100, Italy

Location

Ospedale Civile Pescara

Pescara, 65100, Italy

Location

Azienda Ospedaliera Pisana

Pisa, Italy

Location

Azienda Ospedaliera San Carlo - Potenza

Potenza, 85100, Italy

Location

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

Location

Ospedale S. M. delle Croci

Ravenna, I-48100, Italy

Location

Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Calabria, 89100, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, 42100, Italy

Location

Ospedale Oncologico Regionale

Rionero in Vulture, I-58028, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Azienda Ospedaliera S. Camillo-Forlanini

Rome, 00151, Italy

Location

University Campus Bio-Medico

Rome, 00155, Italy

Location

Istituto Regina Elena

Rome, 00161, Italy

Location

Universita Degli Studi "La Sapeinza"

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

H. San Giovanni-Addolorata Hospital

Rome, 00184, Italy

Location

Ospedale di Ronciglione

Ronciglione, 01037, Italy

Location

IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, 71013, Italy

Location

Istituto di Ematologia Universita - University di Sassari

Sassari, 07100, Italy

Location

Azienda Ospedale E. Morelli

Sondalo, 23039, Italy

Location

Ospedale S. Vincenzo

Taormina, 98039, Italy

Location

Ospedal SS Annunziata

Taranto, 74100, Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10126, Italy

Location

Ospedale Giovanni Bosco

Turin, Italy

Location

Policlinico Universitario Udine

Udine, 33100, Italy

Location

Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Verona, Italy

Location

Related Publications (3)

• Chiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, Falini B, Ronco F, Ferrara F, De Fabritiis P, Luppi M, La Nasa G, Tedeschi A, Califano C, Fanin R, Dore F, Mandelli F, Meloni G, Foa R. A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016 Dec;101(12):1544-1552. doi: 10.3324/haematol.2016.144535. Epub 2016 Aug 11.

  PMID: 27515250 BACKGROUND

• Messina M, Chiaretti S, Iacobucci I, Tavolaro S, Lonetti A, Santangelo S, Elia L, Papayannidis C, Paoloni F, Vitale A, Guarini A, Martinelli G, Foa R. AICDA expression in BCR/ABL1-positive acute lymphoblastic leukaemia is associated with a peculiar gene expression profile. Br J Haematol. 2011 Mar;152(6):727-32. doi: 10.1111/j.1365-2141.2010.08449.x. Epub 2011 Jan 31.

  PMID: 21623761 RESULT

• Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.

  PMID: 34048072 DERIVED

Related Links

• GIMEMA Foundation Website

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginase; Daunorubicin; Etoposide; Idarubicin; Imatinib Mesylate; Mercaptopurine; Methotrexate; Methylprednisolone; Mitoxantrone; Prednisone; Vincristine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Alfonso Piciocchi
• Organization: GIMEMA

a.piciocchi@gimema.it

+39 06 70390513

Study Officials

• Roberto Foa, MD

  Universita Degli Studi "La Sapeinza"

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: October 1, 2004
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-09

Locations

IT (66)