The open-label, dose-escalation trial will evaluate a single infusion of CYAD-01 for the treatment of relapsed/refractory AML and myelodysplastic syndromes (MDS) following preconditioning chemotherapy (cyclophosphamide [300 mg/m[sup.2]] and fludarabine
Shanafelt, M.D., from Stanford University in California, and colleagues randomly assigned 529 patients (aged ≤70 years) with previously untreated CLL in a 2:1 ratio to receive either ibrutinib and rituximab for six cycles (after a single cycle of ibrutinib alone) followed by ibrutinib until disease progression (354 patients) or chemoimmunotherapy with fludarabine
, cyclophosphamide, and rituximab for six cycles (175 patients).
The current standard treatment for CLL patients is an intravenous combination of three drugs -- fludarabine
, cyclophosphamide and rituximab (FCR).
The lymphodepletion regimen will be fludarabine
for 4 days and cyclophosphamide for 3 days.
Hence, standard chemotherapy agents, such as chlorambucil, bendamustine, cladribine or fludarabine
, etc., are not prescribed as first line therapy as they may affect the stem cells.
All subjects will receive low-dose conditioning chemotherapy consisting of cyclophosphamide and fludarabine
(Cy/Flu) and cytokine support with IL-2.
Upon enrollment, patients receive a lymphodepletion regimen consisting of fludarabine
and cyclophasphamide followed by 1x1062x106 CAR T cells/kg, nonmyeloablative conditioning and Haplo-HSCT
Approval was based on randomized phase 3 studies with fludarabine
and cyclophosphamide (FCR) (78,79), bendamustine (BR) (80,81), and chlorambucil (82,83).
High response rate and durable remissions following fludarabine
and rituximab combination therapy for chronic cold agglutinin disease.
His contribution to science include, developed ATRA and Arsenic without chemotherapy for APL newly diagnosed patients, at MD Anderson; subsequently found to be superior to chemotherapy +ATRA, and now the widely accepted treatment for the disease; the first to develop and use FLAG-IDA (fludarabine
containing regimen) in AML and extensive reviewer of AML publications (Blood and JCO) and current Associate Editor of Leukemia.
Fingerle-Rowson et al., "Addition of rituximab to fludarabine
and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial," The Lancet, vol.