A Phase 1/2 interventional study of Allogeneic hematopoietic stem-cell-transplantation in Refractory Acute Leukemia, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 3 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Hadassah Medical Organization · Phase 1/2, Interventional, and Treatment
Refractory acute leukemia (AL) occurs in a significant percentage of the AL patients and presents a therapeutic challenge. Allogeneic stem cell transplantation (allo-SCT) is the only curative option for these patients. Although many of the patients with refractory AL that undergo myeloablative SCT initially achieve complete remission, most relapse later on, and the long-term disease free survival is poor. In order to achieve better leukemic control, most transplant centers employ post transplant early withdrawal of the anti-GVHD immunosuppression; hence exposing the patients to high risk of GVHD associated morbidity and mortality. This study will try to address this common scenario, namely early and late relapse. The investigators will try to attain better leukemic control by re-inducing the patients, 6 weeks after the 1st transplant with further myeloablative treatment (busulfex and thiotepa) followed by allogeneic stem cell support (transplant II).
The effects of feasibility oExperimental design and methods f allo-allo tandem matched stem cell transplantation (AATT) in patients with refractory leukemia will be evaluated in a clinical setting. The current study is limited only for patients with refractory disease that received and failed up to 2 lines of salvage therapy, in good performance status and younger than 50 years old. Only patients that will achieve complete remission after transplant I, will have no major organ dysfunction and with acceptable performance status, will be treated with transplant II. Close monitoring with strict stopping rules including in case of excess transplant related morality, acute or chronic GVHD or graft failure will be employed.
Treatment schedule:
15 patients (divided into 2 cohorts, see below) with matched family member or unrelated donor will be included in single arm open phase I/II trial.
Conditioning protocol:
All patients will be prepared by the same sequential conditioning protocols:
Transplant I: Cy-TBI followed by Transplant II: Busulfan-thiotepa.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 15 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Allogeneic hematopoietic stem-cell-transplantation
2 allogeneic BMTs 6 weeks apart
Transplant-related mortality (TRM) of SCT II.
Time frame: 240d
Transplant-related toxicity (TRT) of SCT II.
Time frame: 240d
Day of neutrophil engraftment at SCT II
Time frame: 240d
Day of platelet engraftment >20x109/L at SCT II
Time frame: 240d
Day of platelet engraftment >50x109/L at SCT II
Time frame: 240d
Acute GVHD occurrence ≥ 2 following SCT II
Time frame: 100d
Time to acute GVHD following SCT II
Time frame: 100d
GVHD grade following SCT II
Time frame: 240d
Overall survival at 180 days from SCT II
Time frame: 180d
Disease free survival at 180 days SCT II
Time frame: 180d
Infections incidence
Time frame: 240d
Immune reconstitution
Time frame: 240d
This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization