Trial Information

Multicenter Randomized Phase II Study to Evaluate the Efficacy of Prophylactic Transfer of CD4 Lymphocytes After T-cell Depleted Reduced Intensity HLA-Identical Sibling Transplantation for Haematological Cancers

OBJECTIVES:

Primary

- To evaluate the effect of prophylactic transfer of donor CD4 cells after T-cell
depleted reduced-intensity HLA-identical sibling transplantation upon the risk of
relapse or progression in patients with haematological cancers (e.g. NHL, HL, CLL/PLL,
PCM, AML, ALL, MDS or CMML depending on the disease status).

Secondary

- To evaluate the effect of prophylactic transfer of donor CD4 cells upon the risk of
graft-versus-host disease (GvHD) in these patients.

- To evaluate the effect of prophylactic transfer of donor CD4 cells upon the rates of
conversion to full donor chimerism in peripheral blood in these patients.

- To determine the effect of prophylactic transfer of donor CD4 cells upon immune
reconstitution in these patients.

- To evaluate the impact of prophylactic transfer of donor CD4 cells upon non-relapse
mortality and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV, melphalan IV, and alemtuzumab IV as reduced intensity
conditioning for T-cell depletion followed by a reduced-intensity HLA-identical sibling stem
cell transplantation on day 0. Withdrawal of cyclosporine immunosuppression therapy commence
at day 40 with tapering over a period of 3-4 weeks, according to the discretion of the PI.
Patients are reassessed between day 70-90 post-transplantation. Patients with stable
engraftment, no significant graft-versus-host disease, and no early relapse or progression
are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive an allogeneic CD4 donor lymphocyte infusion (DLI) at a dose of
1 x10^6 CD4 cells/kg body weight without any other medication once between day 100-120.

- Arm II: Patients receive no further treatment.

Patients undergo blood sample collection for chimerism studies and translational research.

After completion of study treatment, patients are followed up periodically for 1 years and
then annually.

Peer Reviewed and Funded or Endorsed by Leukaemia & Lymphoma Research (LLR)