Dr Jimenez Jimenez on the Clinical Implications of the ACCESS Trial in Hematological Malignancies

Antonio Martin Jimenez Jimenez, MD, associate professor, medicine, University of Miami Sylvester Comprehensive Cancer Center, discusses the clinical implications of the phase 2 ACCESS study (NCT04904588), which evaluated the use of reduced-intensity conditioning therapy, mobilized peripheral blood stem cells (PBSC) from HLA-mismatched unrelated donors (MMUD), and post-transplant cyclophosphamide (PTCy) for graft-vs-host disease (GVHD) prophylaxis in adult patients with hematological malignancies.

The ACCESS study determined that the success observed with bone marrow grafts could be replicated using PBSC in HLA-mismatched settings. Jimenez Jimenez notes that the trial demonstrated that PBSC transplants from MMUD could be performed safely with effective GVHD prophylaxis using PTCy. This treatment approach broadens the donor pool for this population, offering a viable transplant option to a wider range of patients, regardless of race or ethnicity, he says.

, Jimenez Jimenez noted that the ability to perform mismatched and even highly mismatched transplants safely is an important development in ensuring that all patients, irrespective of their racial or ethnic background, have access to potentially life-saving transplant opportunities. The expanded donor pool allows for more specified donor selection, including from younger donors and those without antibodies, thereby optimizing the transplant outcomes, according to Jimenez Jimenez.

Additionally, Jimenez Jimenez explains that the study’s findings underscore the feasibility of selecting donors based on specific criteria, such as blood type and CMV status, further personalizing and enhancing the transplant process. This level of customization is crucial in reducing complications and improving overall survival rates, he emphasizes.

The clinical implications of the ACCESS study are profound, Jimenez Jimenez reports. By demonstrating the safety and efficacy of using PBSC from MMUD with reduced-intensity conditioning and PTCy for GVHD prophylaxis, the study paves the way for more inclusive and optimized transplant options, he says. This advancement ensures safer transplants and enhances the ability to select the best possible donor for each patient, ultimately improving transplant outcomes, Jimenez Jimenez concludes.

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Antonio Martin Jimenez Jimenez, MD, discusses the clinical implications of PBSC from HLA-MMUD and PTCy for GVHD prophylaxis in hematological malignancies.

Dr Jimenez Jimenez on PBSC from HLA-Mismatched Donors in Hematological Malignancies 

Antonio Martin Jimenez Jimenez, MD, associate professor, medicine, the University of Miami Sylvester Comprehensive Cancer Center, discusses findings from the phase 2 ACCESS study (NCT04904588), which evaluated reduced-intensity conditioning therapy, mobilized peripheral blood stem cells (PBSC) from HLA-mismatched unrelated donors (MMUD) and post-transplant cyclophosphamide (PTCy) for graft-vs-host disease (GVHD) prophylaxis in adult patients with hematological malignancies. This study builds on previous data from the multicenter phase 2 15-MMUD trial (NCT02793544).

The primary aim of ACCESS was to determine whether the 1-year overall survival (OS) rate with mobilized PBSC would be comparable with that observed with bone marrow grafts, Jimenez Jimenez says. The results demonstrated an OS rate of 79% (95% CI, 68%-87%) at 1 year post-HCT, which is comparable with the OS rates seen in patients receiving fully matched grafts and consistent with the outcomes in the PTCy arm of the phase 3 BMT CTN 1703 study (NCT03959241), Jimenez Jimenez notes. This OS rate highlights the efficacy of using PBSC from MMUD in the reduced-intensity conditioning setting with PTCy-based GVHD prophylaxis.

Other key outcomes included a GVHD relapse-free survival rate of 51% (95% CI, 39%-62%) at 1 year, indicating that over half of the patients were alive, disease free, and without significant GVHD-related complications at that time point, Jimenez Jimenez explains. This outcome is particularly noteworthy given the use of mismatched grafts, Jimenez Jimenez emphasizes. Additionally, the non-relapse mortality rate with mobilized PBSC was deemed acceptable, reinforcing the safety profile of this approach, according to Jimenez Jimenez.

The estimated incidence of grade 3/4 acute GVHD at 6 months was 9% (95% CI, 3%-16%), and severe chronic GVHD was reported in an estimated 9% (3%-17%) of patients at 1 year. This low rate of severe GVHD underscores the effectiveness of PTCy-based prophylaxis in managing GVHD in this patient population, Jimenez Jimenez states.

, Jimenez Jimenez emphasized that these findings indicate that mobilized PBSC from MMUD, combined with PTCy-based GVHD prophylaxis, offers a viable alternative to bone marrow grafts, providing comparable survival outcomes and a favorable safety profile. The ACCESS study supports the use of mobilized PBSC in this setting, potentially expanding the donor pool for patients requiring allogeneic stem cell transplantation.

Antonio Martin Jimenez Jimenez, MD, discusses conditioning therapy, PBSC from HLA-MMUD, and PTCy for GVHD prophylaxis in hematological malignancies. 

Antonio Martin Jimenez Jimenez, MD

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Dr Jimenez Jimenez on the Clinical Implications of the ACCESS Trial in Hematological Malignancies

Dr Jimenez Jimenez on PBSC from HLA-Mismatched Donors in Hematological Malignancies