Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75
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|ClinicalTrials.gov Identifier: NCT03902665|
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2019
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia, Adult||Drug: Up-front allogeneic hematopoietic stem cell transplantation (HSCT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Up-front Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia Aged 65-75|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||March 15, 2021|
|Estimated Study Completion Date :||March 30, 2021|
Experimental: Allogeneic hematopoietic stem cell transplantation
Day -6, -5 Thiotepa 5 mg/kg/day . Day -4 to -3 Busulfan i. v 3,2 mg/kg/day and fludarabine i.v. 50 mg/m2 /day Day -2 fludarabine i.v. 50 mg/m2 Day -1 Rest Day 0 Begin cyclosporine; Infusion of T cell replete bone marrow transplant Day 1 Begin mycophenolate mofetil Day 3 and 5 Cyclophosphamide 50 mg/kg IV and Mesna Day 6 G-colony stimulating factor
Drug: Up-front allogeneic hematopoietic stem cell transplantation (HSCT)
Patients classified as fit/unfit are included in the HSCT program. There are two early approaches allowed. A) Patients will be left untreated until HSCT B) Patients will receive 1 short course of chemotherapy before HSCT (Ara-C and anthracycline).
Selection of strategy A or B, will be patient based on disease characteristics and dynamics or presence of high tumor load.
Conditioning for haplo-HSCT should be started as soon as possible, within day 45 after initial diagnosis. This is to avoid delayed transplantation. Two dosing levels of the Thiotepa-Busulfan-Fludarabine (TBF) based protocol are allowed based on the clinical condition of the patient: fit patients below 70 will receive the TBF with 2 days of Busulfan, whereas patients with poorer clinical condition or above the age of 70 will receive a dose-reduced TBF, in which Busulfan may be reduced to 1 day only.
Other Name: HSCT
- Rate of complete remission equal or higher than 60% [ Time Frame: From day 56 to day +70 post-transplant ]As a primary outcome measure, the rate of complete remission in treated patients will be evaluated. Complete remission will be assessed from days +56 to days +70 after transplant. A complete remission rate equal to or higher than 60% is expected.
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): NCT03902665
|Fondazione Policlinico Universitario A. Gemelli IRCCS|
|Roma, RM, Italy, 00168|
|Principal Investigator:||Andrea Bacigalupo, Prof.||Fondazione Policlinico Universitario A. Gemelli, IRCCS|