Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

NCT01156883 | Completed

• 3 other identifiers: LAL1308GIMEMA-LAL1308EU-21042
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 43

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. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

B-cell adult acute lymphoblastic leukemia; recurrent adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Treatment feasibility

  To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.

  At 24 months from study entry.

Secondary Outcomes (5)

• Disease free survival

  At three years from study entry

• Event free survival

  At 3 years from study entry

• Overal survival

  At 3 years from study entry

• Safety

  At 3 years from study entry

• Compliance

  At 3 years from study entry

Interventions

asparaginase DRUG

cyclophosphamide DRUG

cytarabine DRUG

daunorubicin hydrochloride DRUG

dexamethasone DRUG

doxorubicin hydrochloride DRUG

ifosfamide DRUG

mercaptopurine DRUG

methotrexate DRUG

methylprednisolone DRUG

prednisone DRUG

thioguanine DRUG

vincristine sulfate DRUG

vindesine DRUG

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoid leukemia, meeting any of the following criteria: * Non-mature B-cell disease * Non-Philadelphia chromosome positive disease * T -cell or B-cell phenotype PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Prior pretreatment with antiblastic chemotherapy allowed

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 (43)

Complesso Ospedaliero S. Giovanni Addolorata

Roma, (RM), 00184, Italy

Location

Azienda Ospedaliera - Nuovo Ospedale "Torrette"

Ancona, Italy

Location

USL 8 - Ospedale S.Donato

Arezzo, Italy

Location

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

Ascoli Piceno, Italy

Location

Az.Ospedaliera S.G.Moscati

Avellino, Italy

Location

UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

Bari, Italy

Location

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

Divisione di Ematologia Ospedale A. Perrino

Brindisi, Italy

Location

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

Catania, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

Catanzaro, Italy

Location

Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna

Ferrara, Italy

Location

Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

Genova, Italy

Location

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

Lecce, Italy

Location

Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"

Messina, Italy

Location

Ospedale Niguarda " Ca Granda"

Milan, Italy

Location

Centro Oncologico Modenese - Dipartimento di Oncoematologia

Modena, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

Napoli, Italy

Location

UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale"

Napoli, Italy

Location

zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, Italy

Location

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

Nocera Inferiore, Italy

Location

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

Location

Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

Palermo, Italy

Location

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

Location

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, Italy

Location

S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Italy

Location

Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia

Pisa, Italy

Location

Dipartimento Oncologico - Ospedale S.Maria delle Croci

Ravenna, Italy

Location

Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

Reggio Calabria, Italy

Location

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

Roma, Italy

Location

Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo

Roma, Italy

Location

Divisione Ematologia - Università Campus Bio-Medico

Roma, Italy

Location

S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

Roma, Italy

Location

U.O.C. Ematologia - Ospedale S.Eugenio

Roma, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

Location

Università degli Studi - Policlinico di Tor Vergata

Roma, Italy

Location

Universita Degli Studi "La Sapeinza"

Rome, 00161, Italy

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

Sassari, Italy

Location

Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani

Trani, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, 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 (1)

• 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

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Ifosfamide; Mercaptopurine; Methotrexate; Methylprednisolone; Prednisone; Thioguanine; Vincristine; Vindesine

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Oxazines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Prednisolone; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Roberto Foa, MD

  Universita Degli Studi "La Sapeinza"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: July 5, 2010
• Study Start: April 1, 2010
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (43)