Clinical Research Directory

Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML

This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.

APOLLO: Personalized rehAbilitation PrOgram in aLLOgeneic Bone Marrow Transplantation

People who undergo allogeneic bone marrow transplant for blood cancers receive the highest chemotherapy doses possible that humans can receive and still survive. As a result, they have devastating side effects during the procedure and for many years afterwards. Damage to organs and muscles cause long-lasting physical weakness and the psychological experience is severe enough to be termed 'post traumatic stress disorder' that also lasts for many years. These effects are worsened by the fact that most Canadians live several hours away from treatment and transplant centers, leaving them entirely on their own to manage these difficult long term effects. The APOLLO team will perform a qualitative study to learn the experiences of people undergoing allogeneic bone marrow transplant while they receive access to a supportive care computer 'app' and telephone support from nursing, exercise and nutrition experts. In this way, the APOLLO team will learn the most helpful type and timing of supportive care from those who know best.

Wharton Jelly Mesenchymal Stromal Cells as GVHD Prophylaxis

Despite progress in chemotherapy, targeted therapy and immunotherapy, allogeneic hematopoietic stem cell transplantation (allo-SCT) is still the only curative procedure for some hematological malignancies. The probability of finding a matched sibling donor (MSD) is estimated under the classical 30%, because of the age of patients and their relatives, and a matched unrelated donor (MUD) can take time to identify. Currently in France, 25% of the allo-SCT are performed with an haplo-identical related donor. The Baltimore group developed an approach using haploidentical related donors, RIC, T-replete bone marrow and post-transplant high dose cyclophosphamide (PTCy) in patients with advanced hematological malignancies. PTCy has shown to eradicate alloreactive donor and host T-cells, activated by respective antigens, thereby reducing the incidence of graft versus host disease (GvHD) but delaying hematopoietic recovery. Therefore, the main source of graft is peripheral blood stem cells (PBSC) mobilized by G-CSF in France. Unfortunately, with PBSC we observe a higher cumulative incidence of GvHD (around 50%) and a higher toxicity-related mortality (TRM), especially for recipients \>50 years old. The co-transplantation of Mesenchymal Stem Cells (MSC) at the time of transplantation has previously shown a double interest in GvHD immunomodulation and hematopoiesis support. Pre-clinical studies (in mice) have shown that mesenchymal stromal cells (MSCs) from Wharton's Jelly reduce the incidence of GvHD when the infusions are weekly repeated. We propose a phase I clinical trial to find the maximum tolerated dose (MTD) of a weekly infusion of WJ-MSC administered as GvHD prophylaxis and as a support for a faster hematological reconstitution after haplo-identical allo-SCT.