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Bosutinib in Elderly Chronic Myeloid Leukemia

NCT02810990 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-02-03

No results posted yet for this study

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

Interventions

DRUG

Bosutinib

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).

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Fausto Castagnetti · Department of Hematology, S. Orsola-Malpighi University of Bologna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-17
Primary Completion
2020-04-30
Completion
2022-06-22

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810990 on ClinicalTrials.gov