At a glance
ClinicalIndex Comparison Record- ✓Male and female patients aged 18 years or older
- ✓Diagnosis of eligible hematologic malignancy: AML, ALL (including T-LBL with marrow involvement), MDS, or CML for which allogeneic hematopoietic peripheral blood cell transplantation is clinically appropriate
- ✓Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mobilized peripheral blood donor
- ✓Mobilized peripheral blood donor collection meeting protocol specifications
- ✕Phase 2: Bone marrow fibrosis grade 3 (severe) or greater
- ✕Positive serology for HIV or HTLV at any time prior to enrollment
- ✕Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy)
- ✕Prior autologous or allogeneic hematopoietic cell transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ProTmune and Control Arm for Hematologic Malignancies and 5 related conditions. Completed, enrolled 96 participants across 15 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Ex-vivo, programmed mobilized peripheral blood (mPB) cells
Untreated mobilized peripheral blood (mPB) cells