Treatment of Adult Ph+ LAL With BMS-354825
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ClinicalTrials.gov Identifier: NCT00391989 |
Recruitment Status
:
Completed
First Posted
: October 25, 2006
Results First Posted
: January 26, 2015
Last Update Posted
: January 4, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoblastic Leukemia, Acute | Drug: Dasatinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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. |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

- 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). [ Time Frame: End of the study, up to day 85 ]
- The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities; [ Time Frame: End of study ]
- The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug; [ Time Frame: End of study ]
- the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug; [ Time Frame: 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; [ Time Frame: End of study ]
- the Cumulative Incidence of Relapse; [ Time Frame: End of study ]
- OS, Defined as the Time Interval Between Inclusion and Death for Any Cause. [ Time Frame: End of study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391989
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" - Div. TERE | |
Napoli, Italy | |
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" | |
Napoli, Italy | |
Ematologia Università Federico II | |
Napoli, Italy | |
Ospedale S. Luigi Gonzaga | |
Orbassano, Italy | |
Dip. Oncologico "La Maddalena" | |
Palermo, Italy | |
Div. di Ematologia - A.O. "V. Cervello" | |
Palermo, Italy | |
Università degli Studi di Palermo - A.U. Policlinico | |
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 | |
Ospedale S. Camillo | |
Rome, Italy | |
Ospedale S.Eugenio | |
Rome, Italy | |
Università Cattolica del Sacro Cuore | |
Rome, Italy | |
Università degli Studi di Roma "La Sapienza" | |
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 |
Principal Investigator: | Robin Foà, MD, PhD | Università degli Studi di Roma "La Sapienza", Dipartimento di Biotecnologie Cellulari ed Ematolgia |
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 |
First Posted: | October 25, 2006 Key Record Dates |
Results First Posted: | January 26, 2015 |
Last Update Posted: | January 4, 2017 |
Last Verified: | November 2016 |
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 Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Dasatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |