Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

November 29, 2018

Study Completion Date

February 29, 2020

Conditions
LeukemiaMyelogenousChronicBCR-ABL Positive
Interventions
DRUG

Bosutinib

Subjects will receive 400mg of bosutinib once daily from day +30 after transplant, by mouth with food, preferably in the morning. Bosutinib will also be administered from day at least -45 to day -15 to assess the sensitivity of patient CML to this TKI.

PROCEDURE

Bone Marrow Transplant

"Samples of the unrelated stem cell graft shall be characterised with respect to the number of CD34 positive cells per kg body weight of the recipient.~The number of transplanted CD34 positive cells per kg body weight (BW) of the recipient shall be recorded in the Case Report Form (CRF). If the transplant was cryopreserved the number of viable CD34 positive cells has to be determined after thawing and documented.~The goal is to transplant \> 3 x 106 CD34+ cells/kg BW recipient from bone marrow or \> 3 x 108 nucleated cells/kg BW recipient from bone marrow"

DRUG

Bone Marrow cells

Trial Locations (2)

20132

Ospedale San Raffaele, Milan

20900

ASST-Monza, Monza

All Listed Sponsors
collaborator

IRCCS San Raffaele

OTHER

lead

University of Milano Bicocca

OTHER

NCT02638467 - Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy | Biotech Hunter | Biotech Hunter