Treatment of Adult Ph+ LAL With BMS-354825

NCT00391989 | Completed Phase 2 Results

• 1 other identifier: LAL1205
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 36

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.

Conditions

Lymphoblastic Leukemia, Acute

Keywords

Ph+ Acute Lymphoblastic Leukaemia; Dasatinib; targeted therapy; Patients with Ph positive and or BCR ABL positive ALL

Outcome Measures

Primary Outcomes (1)

• 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).

  End of the study, up to day 85

Secondary Outcomes (6)

• The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;

  End of study

• The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;

  End of study

• the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;

  End of study

• DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;

  End of study

• the Cumulative Incidence of Relapse;

  End of study

Interventions

Dasatinib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (36)

Ospedale San Donato USL 8

Arezzo, Arezzo, Italy

Location

Università degli Studi di Bari

Bari, Bari, Italy

Location

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

Bologna, Bologna, Italy

Location

Azienda Spedali Civili

Brescia, Brescia, Italy

Location

Osp. Reg. A. Di Summa

Brindisi, Brindisi, Italy

Location

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

Cagliari, Cagliari, Italy

Location

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

Catania, Catania, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Catanzaro, Italy

Location

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

Ferrara, Ferrara, Italy

Location

Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

Genova, Genova, Italy

Location

Ospedale Niguarda " Ca Granda"

Milan, Milano, Italy

Location

Sez. di medicina Interna Oncologia ed Ematologia

Modena, Modena, Italy

Location

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

Napoli, Napoli, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

Napoli, Napoli, Italy

Location

Ematologia Università Federico II

Napoli, Napoli, Italy

Location

Ospedale S. Luigi Gonzaga

Orbassano, Orbassano, Italy

Location

Dip. Oncologico "La Maddalena"

Palermo, Palermo, Italy

Location

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

Palermo, Palermo, Italy

Location

Università degli Studi di Palermo - A.U. Policlinico

Palermo, Palermo, Italy

Location

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, Pavia, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Pescara, Italy

Location

Istituto di Ematologia- Ospedale San Carlo

Potenza, Potenza, Italy

Location

Ospedale S.Maria delle Croci

Ravenna, Ravenna, Italy

Location

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

Reggio Calabria, Reggio Calabria, Italy

Location

Ospedale S. Camillo

Rome, Rome, Italy

Location

Ospedale S.Eugenio

Rome, Rome, Italy

Location

Università Cattolica del Sacro Cuore

Rome, Rome, Italy

Location

Università degli Studi di Roma "La Sapienza"

Rome, Rome, Italy

Location

Università degli Studi di Tor Vergata

Rome, Rome, Italy

Location

Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

Sassari, Sassari, Italy

Location

Policlinico Universitario

Udine, Udine, Italy

Location

Policlinico G.B. Rossi

Verona, Verona, Italy

Location

Ospedale Sant'Anna-17

Ronciglione, Viterbo, Italy

Location

Nuovo Ospedale "Torrette"

Ancona, Italy

Location

Presidio Ospedaliero "C. e G.Mazzoni"

Ascoli Piceno, Italy

Location

Ospedale Casa Sollievo della sofferenza

San Giovanni Rotondo, Italy

Location

Related Publications (2)

• 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.

  PMID: 21931113 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Paola Fazy; Dr. Marco Vignetti
• Organization: GIMEMA

gimema@gimema.it

+39 06.70390521

Study Officials

• Robin Foà, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 25, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 4, 2017
• Results First Posted: January 26, 2015

Record last verified: 2016-11

Locations

IT (36)