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

Leukemia Clinical Trial

— LAL0904  

Official title:

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458848
• Other study ID #: LAL0904
• Secondary ID: LAL09042004-0017
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: March 2014

Study information

• Verified date: September 2018
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• asparaginase

• daunorubicin hydrochloride

• etoposide

• idarubicin

• imatinib mesylate

• mercaptopurine

• methotrexate

• methylprednisolone

• mitoxantrone hydrochloride

• prednisone

• vincristine sulfate

Procedure:
• allogeneic hematopoietic stem cell transplantation

• autologous hematopoietic stem cell transplantation

• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Italy	Ospedale Civile Alessandria	Alessandria
Italy	Ospedale Torrette University Ancona	Ancona
Italy	Ospedale S. Donato	Arezzo
Italy	Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"	Ascoli Piceno
Italy	S.G. Moscati Hospital	Avellino
Italy	Universita Degli Studi di Bari	Bari
Italy	University of Bologna Medical School	Bologna
Italy	Spedali Civili di Brescia	Brescia
Italy	A. Perrino Hospital	Brindisi
Italy	Ospedale Binaghi	Cagliari
Italy	Ospedale Ferrarotto	Catania
Italy	Ospedale Regionale A. Pugliese	Catanzaro
Italy	U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza	Cosenza
Italy	Universita di Ferrara	Ferrara
Italy	Azienda Ospedaliera di Firenze	Florence
Italy	Ospedali Riuniti Foggia	Foggia
Italy	Ospedale Umberto I	Frosinone
Italy	Ospedale S. Antonio Abate	Gallarate
Italy	Ospedale San Martino	Genoa
Italy	Ospedale L'Aquila	L'Aquila
Italy	Ospedale Santa Maria Goretti	Latina
Italy	Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE	Lecce
Italy	Ospedale Maggiore Lodi	Lodi
Italy	Azienda Ospedaliera Universitaria - Policlinico G. Martino	Messina
Italy	Ospedale Niguarda Ca'Granda	Milan
Italy	Azienda Ospedaliera - Universitaria di Modena	Modena
Italy	Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli	Naples
Italy	Federico II University Medical School	Naples
Italy	Ospedale S. Gennaro ASL NA1	Naples
Italy	Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I	Nocera Inferiore
Italy	Amedeo Avogadro University of Eastern Piedmont	Novara
Italy	Ospedale San Francesco	Nuoro
Italy	Azienda Ospedale S. Luigi at University of Torino	Orbassano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Ospedale Cervello	Palermo
Italy	Ospedale La Maddalena - Palermo	Palermo
Italy	Policlinico - Cattedra di Ematologia	Palermo
Italy	Fondazione I.R.C.C.S. Policlinico San Matteo	Pavia
Italy	University of Pavia	Pavia
Italy	Perugia Regional Cancer Center	Perugia
Italy	Azienda Ospedale - d S. Salvatore	Pesaro
Italy	Ospedale Civile Pescara	Pescara
Italy	Azienda Ospedaliera Pisana	Pisa
Italy	Azienda Ospedaliera San Carlo - Potenza	Potenza
Italy	Ospedale S. M. delle Croci	Ravenna
Italy	Ospedale Sta. Maria Delle Croci	Ravenna
Italy	Azienda Ospedaliera Bianchi Melacrino Morelli	Reggio Calabria
Italy	Arcispedale S. Maria Nuova	Reggio Emilia
Italy	Ospedale Oncologico Regionale	RIONERO in VULTURE
Italy	Azienda Ospedaliera S. Camillo-Forlanini	Rome
Italy	H. San Giovanni-Addolorata Hospital	Rome
Italy	Istituto Regina Elena	Rome
Italy	Ospedale Sant' Eugenio	Rome
Italy	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Rome
Italy	Universita Degli Studi "La Sapeinza"	Rome
Italy	University Campus Bio-Medico	Rome
Italy	Ospedale di Ronciglione	Ronciglione
Italy	IRCCS "Casa Sollievo della Sofferenza"	San Giovanni Rotondo
Italy	Istituto di Ematologia Universita - University di Sassari	Sassari
Italy	Azienda Ospedale E. Morelli	Sondalo
Italy	Ospedale S. Vincenzo	Taormina
Italy	Ospedal SS Annunziata	Taranto
Italy	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino	Turin
Italy	Ospedale Giovanni Bosco	Turin
Italy	Policlinico Universitario Udine	Udine
Italy	Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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, Foà 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. Epub 2016 Aug 11. — View Citation

Messina M, Chiaretti S, Iacobucci I, Tavolaro S, Lonetti A, Santangelo S, Elia L, Papayannidis C, Paoloni F, Vitale A, Guarini A, Martinelli G, Foà R. AICDA expression in BCR/ABL1-positive acute lymphoblastic leukaemia is associated with a peculiar gene e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reaching Disease Free Survival		At 60 months
Secondary	Number of Patients Reaching Complete Hematological Response After Induction Therapy		At the end of induction, day +50
Secondary	Percentage of Participants Reaching Overall Survival	Overall survival from diagnosis	At 60 months

External Links

•   GIMEMA Foundation Website