Treatment of Adult Ph+ LAL With BMS-354825

NCT ID: NCT00391989

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

Brief Summary

The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.

Detailed Description

This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.

Conditions

Lymphoblastic Leukemia, Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Dasatinib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with Ph+ and/or BCR/ABL+ ALL
• Age ≥18 years old
• De novo ALL (within 14 days from diagnosis)
• No prior treatment with any anti-leukemic drugs with the exception of steroids for no more than 14 days (including the 7-day pretreatment already scheduled in the protocol)
• WHO performance status ≤2
• Absence of central nervous system (CNS) leukemia
• Normal serum level of potassium, total calcium corrected for serum albumin magnesium and phosphorus, or correctable with supplements
• ALT and AST ≤2.5 x ULN or ≤5.0 x ULN if considered due to leukemia
• Alkaline phosphatase ≤2.5 x ULN unless considered to leukemia
• Serum bilirubin ≤2 x ULN
• Serum creatinine ≤3 x ULN
• Serum amylase ≤1.5 x ULN and serum lipase ≤1.5 x ULN
• Normal cardiac function
• Written informed consent prior to any study procedures being performed.

Exclusion Criteria

• Impaired cardiac function, including any one of the following:
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BMS-354825 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)
• Use of therapeutic warfarin
• Acute or chronic liver or renal disease considered unrelated to leukemia
• Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
• Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM¬CSF) ≤1 week prior to starting study drug
• Patients who are currently receiving treatment with any of the medications listed in "Appendix F" and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in "Appendix F" have the potential to prolong the QT interval.
• Patients who have received any anti-leukemic agents and treatments including steroids for more than 14 days including 7 days pretreatment that is part of the protocol
• Patients who have received any investigational drug in the last 2 weeks
• Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of BMS-354825). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
• Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
• Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
• Non compliant to oral medication patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Foà, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Roma "La Sapienza", Dipartimento di Biotecnologie Cellulari ed Ematolgia

Locations

Ospedale San Donato USL 8

Arezzo, Arezzo, Italy

Università degli Studi di Bari

Bari, Bari, Italy

Ist.Ematologia e Oncologia Medica L.e A. Seragnoli

Bologna, Bologna, Italy

Azienda Spedali Civili

Brescia, Brescia, Italy

Osp. Reg. A. Di Summa

Brindisi, Brindisi, Italy

Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi

Cagliari, Cagliari, Italy

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

Catania, Catania, Italy

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Catanzaro, Italy

Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna

Ferrara, Ferrara, Italy

Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

Genova, Genova, Italy

Ospedale Niguarda " Ca Granda"

Milan, Milano, Italy

Sez. di medicina Interna Oncologia ed Ematologia

Modena, Modena, Italy

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Div. TERE

Napoli, Napoli, Italy

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

Napoli, Napoli, Italy

Ematologia Università Federico II

Napoli, Napoli, Italy

Ospedale S. Luigi Gonzaga

Orbassano, Orbassano, Italy

Dip. Oncologico "La Maddalena"

Palermo, Palermo, Italy

Div. di Ematologia - A.O. "V. Cervello"

Palermo, Palermo, Italy

Università degli Studi di Palermo - A.U. Policlinico

Palermo, Palermo, Italy

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, Pavia, Italy

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Pescara, Italy

Istituto di Ematologia- Ospedale San Carlo

Potenza, Potenza, Italy

Ospedale S.Maria delle Croci

Ravenna, Ravenna, Italy

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

Reggio Calabria, Reggio Calabria, Italy

Ospedale S. Camillo

Rome, Rome, Italy

Ospedale S.Eugenio

Rome, Rome, Italy

Università Cattolica del Sacro Cuore

Rome, Rome, Italy

Università degli Studi di Roma "La Sapienza"

Rome, Rome, Italy

Università degli Studi di Tor Vergata

Rome, Rome, Italy

Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

Sassari, Sassari, Italy

Policlinico Universitario

Udine, Udine, Italy

Policlinico G.B. Rossi

Verona, Verona, Italy

Ospedale Sant'Anna-17

Ronciglione, Viterbo, Italy

Nuovo Ospedale "Torrette"

Ancona, , Italy

Presidio Ospedaliero "C. e G.Mazzoni"

Ascoli Piceno, , Italy

Ospedale Casa Sollievo della sofferenza

San Giovanni Rotondo, , Italy

Countries

Italy

References

Foa R, Vitale A, Vignetti M, Meloni G, Guarini A, De Propris MS, Elia L, Paoloni F, Fazi P, Cimino G, Nobile F, Ferrara F, Castagnola C, Sica S, Leoni P, Zuffa E, Fozza C, Luppi M, Candoni A, Iacobucci I, Soverini S, Mandelli F, Martinelli G, Baccarani M; GIMEMA Acute Leukemia Working Party. Dasatinib as first-line treatment for adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood. 2011 Dec 15;118(25):6521-8. doi: 10.1182/blood-2011-05-351403. Epub 2011 Sep 19.

Reference Type: DERIVED

PMID: 21931113 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21623761 (View on PubMed)

Other Identifiers

LAL1205

Identifier Type: -

Identifier Source: org_study_id