Bosutinib in Elderly Chronic Myeloid Leukemia

NCT02810990 | Completed Phase 2 DMC

• 2 other identifiers: CML15162016-002216-40
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 45

Brief Summary

The objective of the present study is to evaluate a new drug called bosutinib as it is believed that this agent may be able to predict an excellent prognosis in patients that did not obtain any benefit with other drugs before. Still, this needs to be proved and we hope this study is able to do so.

Conditions

Chronic Myeloid Leukemia

Keywords

bosutinib; chronic myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Number of patients who are in major molecular response (MMR)

  One year treatment

Secondary Outcomes (7)

• Number of patients who obtain molecular response

  At 6 and 12 months from treatment start

• Number of patients discontinuing treatment for failure, adverse events or other reasons

  At 12 and 36 months

• Number of Adverse Events (AEs)

  At 36 months

• Number of patients alive

  At 36 months

• Number of patients on treatment at 200, 300 and 400 mg or more daily

  At 6, 12 and 36 months

Study Arms (1)

Bosutinib treatment

EXPERIMENTAL

Drug: Bosutinib

Interventions

Bosutinib DRUG

Bosutinib is given orally accordingly with this scheme: A. 200 mg OD: starting dose ("wash-in" period) at week 1 and week 2 B. 300 mg OD: from week 3 to the end of week 16 At the end of week 12 evaluation of molecular response (BCR-ABL1 level by RT-Q-PCR). Bosutinib dose is then managed as follows : C1. if BCR-ABL1 ≤1% at week 12: 300 mg OD from week 17 to week 52 C2. if BCR-ABL1 \> 1% at week 12: 400 mg OD from week 17 to week 52 All the responsive patients who are still on Bosutinib at the end of week 52, will continue Bosutinib at the same dose (300 mg OD or 400 mg OD) for the next two years ( if tolerated and in absence of safety concerns).

Bosutinib treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Molecular confirmed diagnosis of BCR-ABL1+ CML
• Chronic phase CML (ELN 2013 criteria)
• years of age or older
• Prior first-line treatment with any other TKIs
• Intolerance to prior treatment, based on investigator and patient assessment or failure of prior treatment according to any one of the ELN 2013 criteria, as listed below
• Non complete hematologic response (CHR) at 3 months
• No cytogenetic response (Ph+ \> 95%) at 6 months
• Less than Partial Cytogenetic Response (PCyR) (Ph+ \>35%) at 6 months
• BCR-ABL1 \> 10% at 6 months
• Non complete CyR (CCyR) (Ph+ \> 0) at 12 months
• BCR-ABL1 \> 1% at 12 months
• Loss of CHR at any time
• Loss of CCyR at any time
• Confirmed loss of major molecular response (MMR) (BCR-ABL1 \> 0.1%) in two consecutive tests, of which one \> 1%, at any time
• An effective form of contraception from enrolment through 30 days after the end of treatment

You may not qualify if:

• Accelerated or blastic phase CML (according to ELN 2013 criteria)
• Patients with the T315I or the V299L mutation
• Patients previously treated with 2 TKIs or more
• Compelled to take medications that are known to be associated with Torsades de Pointes and/or with significant QTc prolongation
• Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug
• HBV markers positivity
• Lack of informed consent

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (45)

S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

Ancona, Italy

Location

UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

Bari, Italy

Location

Fausto Castagnetti

Bologna, Italy

Location

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, Italy

Location

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

Catania, Italy

Location

S.C. Ematologia ASO S. Croce e Carle

Cuneo, Italy

Location

Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia

Ferrara, Italy

Location

Policlinico di Careggi

Florence, Italy

Location

Struttura Complessa di Ematologia Ospedali Riuniti Foggia

Foggia, Italy

Location

IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

Genova, Italy

Location

ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Lecce, Italy

Location

Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

Meldola, Italy

Location

Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

Messina, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia

Milan, Italy

Location

U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele

Milan, Italy

Location

Unità Trapianto di Midollo Ist. Nazionale Tumori

Milan, Italy

Location

Azienda Ospedaliera "S.Gerardo"

Monza, Italy

Location

Azienda Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, Italy

Location

S.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

Location

Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2

Orbassano, Italy

Location

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

Padua, Italy

Location

U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"

Palermo, Italy

Location

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, Italy

Location

S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto

Piacenza, Italy

Location

Ematologia - Ospedale San Carlo

Potenza, Italy

Location

Dipartimento Oncologico - Ospedale S.Maria delle Croci

Ravenna, Italy

Location

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

Ospedale "Infermi"

Rimini, Italy

Location

U.O. di Ematologia - Centro Oncologico Basilicata

Rionero in Vulture, Italy

Location

Complesso Ospedaliero S. Giovanni Addolorata

Roma, Italy

Location

Divisione Ematologia - Università Campus Bio-Medico

Roma, Italy

Location

Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo

Roma, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

Location

UOC Pronto Soccorso - Dipartimento Biotecnologie Cellulari Università di Roma "Sapienza"

Roma, Italy

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

Siena, Italy

Location

A.O. Santa Maria - Terni S.C Oncoematologia

Terni, Italy

Location

Divisione di Ematologia - "Città della Salute e della Scienza di Torino"

Torino, Italy

Location

S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

Torino, Italy

Location

Clinica Ematologica-Centro Trapianti e Terapie cellulari

Udine, Italy

Location

Medicina Interna I - Ospedale di Circolo

Varese, Italy

Location

A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Verona, Italy

Location

Related Links

• GIMEMA Foundation website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fausto Castagnetti

  Department of Hematology, S. Orsola-Malpighi University of Bologna

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 23, 2016
• Study Start: November 17, 2016
• Primary Completion: April 30, 2020
• Study Completion: June 22, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (45)