This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
Male or female aged 18-70 years
Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
Karnofsky performance >70%
Inability to comply with medical recommendations or follow-up
Pregnancy
Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
Has active CNS or ocular disease involvement within 3 months
Single group
Fludarabine
DrugGiven Day-5, Day-4, Day-3, Day-2
Melphalan
DrugGiven Day-5
Total Body Irradiation
RadiationGiven Day-1
Progression-free survival (PFS)
PFS is defined as the time from stem cell infusion to time of disease relapse or death from any cause; data for patients who were alive without relapse will be censored at the date of last contact.
Overall survival (OS)
OS is defined as the time from stem cell infusion until death from any cause. Data of patients who were alive without relapse will be censored at the date of last contact.
Cumulative incidence of Graft-Versus-Host-Free, relapse-free survival (GRFS)
GRFS is defined as time from stem cell infusion to time of the first event among acute GVHD grades 3-4, extensive chronic GVHD, relapse, and death. Data of patients who are event-free will be censored at the date of last contact.
Cumulative incidence of relapse
Relapse is defined as re-occurrence of the disease after stem cell infusion. Cumulative incidence of relapse will be measured from date of stem cell infusion to date of disease relapse. Death without disease relapse is considered a competing risk for relapse. Data of patients who are alive without disease relapse will be censored at the date of last contact.
Cumulative incidence of Non-Relapse Mortality (NRM)
NRM is defined as death related to AHSCT during continuous complete remission. Cumulative incidence of NRM will be measured from date of stem cell infusion to date of death. Disease relapse is considered a competing risk for NRM. Data of patients who are alive without disease relapse will be censored at the date of last contact.
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