A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies
This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.
• Male and female patients aged 18 years and older, inclusive;
• Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate.
• Eligible diseases and stages include the following:
‣ Acute myeloid leukemia
‣ Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement
‣ Myelodysplastic Syndrome
‣ Chronic myelogenous leukemia
• Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
• mBP donor collection that meets protocol specifications;
• Adequate performance status, defined as Karnofsky score greater than or equal to 70%;
• For female patients of childbearing potential, all of the following criteria must be met:
‣ They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
⁃ They are not breastfeeding;
⁃ They do not plan to become pregnant during the study; and
⁃ They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile.
• For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
• Willingness and ability to sign an IRB/IEC-approved ICF before performance of any study-specific procedures or tests and to comply with protocol visits, and study procedures.