Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy
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|ClinicalTrials.gov Identifier: NCT02638467|
Recruitment Status : Unknown
Verified April 2018 by University of Milano Bicocca.
Recruitment status was: Recruiting
First Posted : December 23, 2015
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelogenous Chronic BCR-ABL Positive||Drug: Bosutinib Procedure: Bone Marrow Transplant Drug: Bone Marrow cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Haematopoietic Stem Cell Transplantation From a Matched Donor in Patients With Chronic Myeloid Leukemia Failing to Gain Normal Hemopoiesis Under TKIs Therapy|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Bosutinib and Bone Marrow Transplant
Subjects will receive 400mg of bosutinib from day at least -45 to day -15 to assess the sensitivity of patient Chronic Myeloid Leukemia (CML) to this TKI. Patients will be transplanted with the aim to transplant > 3 x 106 CD34+ cells/kg Body Weight (BW) recipient from bone marrow or > 3 x 108 nucleated cells/kg BW recipient from bone marrow. Then, subjects will receive 400mg of bosutinib once daily from day +30 after transplant.
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
- Efficacy as assessed by the percentage of patients with Complete Cytogenetic Response (CCyR) [ Time Frame: 12 months ]The percentage of patients with Complete Cytogenetic Response (CCyR) will be calculated as the complement to the percentage of failures on the total number of patients treated, where failure includes the following events: no engraftment, death within 12 months, no CCyR at 12 months.
- Overall Survival [ Time Frame: 12 months ]
- Percentage of patients with engraftment [ Time Frame: 12 months ]
- percentage of patients with complete chimerism (95%) [ Time Frame: Day +28, +56 and +100 ]
- Evaluation of Major Cytogenetic Response (MCyR) [ Time Frame: 12 months ]Major Cytogenetic Response (MCyR) is < 36% Ph+ metaphases
- Evaluation of molecular responses [ Time Frame: 12 months ]
Molecular response is defined
- Complete: if there is undetectable BCR-ABL transcript
- Major: if ratio BCR/ABL <= 0.1% on International Scale
- Relapse incidence (RI) [ Time Frame: 12 months ]
- Incidence of non-relapse mortality (NRM) [ Time Frame: Within day +28 and +360 ]
- Incidence and severity of acute and chronic graft vs. host disease (GvHD) [ Time Frame: 12 months ]
- Quality of Life (QoL) [ Time Frame: 12 months ]Evaluation of QoL with EQ-5D-5L (Italian - Version 2) and FACT-Leu (Italian -Version 4)
- Overall Survival (OS) [ Time Frame: 36 months ]2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses)
- Progression Free Survival (PFS) [ Time Frame: 36 months ]2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses)
- Relapse Incidence (RI) [ Time Frame: 36 months ]2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses)
- Chronic Graft-versus-host Disease (cGvHD) [ Time Frame: 36 months ]
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): NCT02638467
|Contact: Carlo Gambacorti-Passerini, MDemail@example.com|
|Monza, Italy/MB, Italy, 20900|
|Contact: Carlo Gambacorti-Passerini, MD +390392339553 firstname.lastname@example.org|
|Principal Investigator: Carlo Gambacorti-Passerini, MD|
|Ospedale San Raffaele||Recruiting|
|Milano, MI, Italy, 20132|
|Contact: Fabio Ciceri, MD +390226437703 email@example.com|
|Principal Investigator:||Carlo Gambacorti-Passerini, MD||University of Milano Bicocca|