Treatment of Adult Ph+ LAL With BMS-354825

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00391989
First received: October 24, 2006
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Lymphoblastic Leukemia, Acute
Drug: Dasatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) With the Protein Tyrosine Kinase Inhibitor BMS-354825. EudraCT Number 2005-005107-42.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Rate of hematological complete remission (HCR)obtained during the BMS induction treatment within day +85 from the start of BMS (i.e., whenever achieved from the start of the experimental drug).

Secondary Outcome Measures:
  • the incidence of grade >2 CTC-NCI side effects and toxicities;
  • the best cytogenetic response obtained during BMS treatment within day +85, whenever achieved from the start of the experimental drug;
  • the best molecular response obtained during BMS treatment within day +85, whenever achieved from the start of the experimental drug;
  • DFS, defined as the time interval between the evaluation of HCR and hematological relapse of the disease or death in first HCR;
  • the cumulative incidence of relapse;
  • OS, defined as the time interval between inclusion and death for any cause.

Enrollment: 48
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391989

Locations
Italy
Ospedale Sant'Anna-17
Ronciglione, Viterbo, Italy
Nuovo Ospedale "Torrette"
Ancona, Italy
Ospedale San Donato USL 8
Arezzo, Italy
Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno, Italy
Università degli Studi di Bari
Bari, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Italy
Azienda Spedali Civili
Brescia, Italy
Osp. Reg. A. Di Summa
Brindisi, Italy
Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
Cagliari, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, Italy
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
Genova, Italy
Ospedale Niguarda " Ca Granda"
Milano, Italy
Sez. di medicina Interna Oncologia ed Ematologia
Modena, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy
Ematologia Università Federico II
Napoli, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Div. TERE
Napoli, Italy
Ospedale S. Luigi Gonzaga
Orbassano, Italy
Università degli Studi di Palermo - A.U. Policlinico
Palermo, Italy
Div. di Ematologia - A.O. "V. Cervello"
Palermo, Italy
Dip. Oncologico "La Maddalena"
Palermo, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo
Pavia, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Istituto di Ematologia- Ospedale San Carlo
Potenza, Italy
Ospedale S.Maria delle Croci
Ravenna, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Università degli Studi di Roma "La Sapienza"
Rome, Italy
Università Cattolica del Sacro Cuore
Rome, Italy
Ospedale S. Camillo
Rome, Italy
Ospedale S.Eugenio
Rome, Italy
Università degli Studi di Tor Vergata
Rome, Italy
Ospedale Casa Sollievo della sofferenza
San Giovanni Rotondo, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari, Italy
Policlinico Universitario
Udine, Italy
Policlinico G.B. Rossi
Verona, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Robin Foà, MD, PhD Università degli Studi di Roma "La Sapienza", Dipartimento di Biotecnologie Cellulari ed Ematolgia
  More Information

No publications provided by Gruppo Italiano Malattie EMatologiche dell'Adulto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00391989     History of Changes
Other Study ID Numbers: LAL1205
Study First Received: October 24, 2006
Last Updated: August 22, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Ph+ Acute Lymphoblastic Leukaemia
Dasatinib
targeted therapy
Patients with Ph positive and or BCR ABL positive ALL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Philadelphia Chromosome
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Disease Attributes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014