Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation
14 patients around the world
Available in Mexico
TMLI will be administered as part of the conventional reduced intensity conditioning scheme
of our institution:
Fludarabine 25 mg/m2 + cyclophosphamide 350 mg/m2 on days -6 to -3, for patients with
positive measurable residual disease TMLI will be added in doses of 12 Gy on days -3 to -1
divided into 6 fractions of 2 Gy every 12 hours for 3 days, which will be administered
through a computed tomography tomotherapy system.
Infusion of peripheral blood hematopoietic stem cells will be performed on day 0 and after
this, prophylaxis for GVHD with post-transplant cyclophosphamide 50 mg/kg will be
administered on days +3 and +4, followed by tacrolimus or cyclosporine A plus mycophenolate
mofetil regardless of HLA matching.
The procedure for the donation of hematopoietic cells will be done through a peripheral blood
apheresis with previous stimulation with filgrastim at 10 mcg/kg for 4 days according to the
standardized procedures of our institution.
The leukocyte and platelet count will be monitored by serial complete blood count, and a bone
marrow aspiration (BMA) and minimal residual disease (MRD) will be performed on day 60 after
transplantation.
Hospital Universitario Dr. Jose E. Gonzalez
14Patients around the world
This study is for people with
Leukemia
Acute lymphoblastic leukemia
Requirements for the patient
To 45 Years
All Gender
Medical requirements
Diagnosis of ALL confirmed by flow cytometry.
Patients between age 16 and 45 years with ALL in first remission, refractory, or relapsing
Patients who have an identical or haploidentical allogeneic donor by high resolution HLA
Patients who do not meet the age previously mentioned.
Patient with comorbidities that rule them out for HSCT, with a Hematopoietic cell transplantation-specific comorbidity index (HCT-CI) greater than 2.
Poor performance status or Karnofsky less than 70%
Transthoracic echocardiogram with alteration in myocardial function with left ventricular ejection fraction (LVEF) less than 50%
Patients who previously and for another reason have already received radiotherapy or who refuse to receive it
SponsorHospital Universitario Dr. Jose E. Gonzalez