Phase 2
N=7
CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML
Acute Myeloid Leukemia · Acute Lymphoblastic Leukemia · Myelodysplastic Syndromes · Acute Leukemia · Chronic Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT04151706 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants Achieving Graft-versus-Host Disease-Free and Relapse-Free Survival (GRFS) Through 1 Year Post-Transplant — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD8+ Memory T Cell Infusion (Drug); Thiotepa (Drug); Fludarabine (Drug); Hyperfractionated TBI (Radiation); Busulfan (Drug); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Robert Lowsky
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Graft-versus-Host Disease-Free and Relapse-Free Survival (GRFS) Through 1 Year Post-Transplant |
4 | — |
| SECONDARY Number of Participants Experiencing Graft Rejection Through 1 Year Post-Transplant |
— | — |
| SECONDARY Number of Participants Experiencing Acute Graft-versus-Host Disease (GvHD) Through 1 Year Post-Transplant |
3 | — |
| SECONDARY Number of Participants With Chronic, Steroid-Requiring Graft-versus-Host Disease (GvHD) Through 1 Year Post-Transplant |
— | — |
| SECONDARY Number of Participants With Non-Relapse Mortality Through 1 Year Post-Transplant Without Recurrence of Myelodysplastic Syndrome or Leukemia |
1 | — |
| SECONDARY Number of Participants Who Experience Relapse Through 1 Year Post-Transplant |
— | — |
| SECONDARY Overall Survival (OS) |
6 | — |
Summary
This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.
Eligibility Criteria
Recipient Inclusion Criteria:
- Acute leukemia, in morphologic complete remission, OR myelodysplasia with 5 mg prednisone daily)
- Seropositive for HIV 1 or 2
- Seropositive for HTLV I or -II
- Active Hepatitis B or C viral replication by polymerase chain reaction (PCR)
- Documented allergy to iron dextran or murine proteins
- Pregnant (positive serum or urine βHCG) or breastfeeding)
- Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use an effective form of birth control or abstinence for one year after transplantation
- Unable to comply with the treatment protocol, including appropriate supportive care, follow up and research tests.
- Planned to receive post transplant maintenance therapy except for fms-like tyrosine kinase 3 (FLT3) inhibitors or BCR ABL tyrosine kinase inhibitors (TKIs).
Donor Inclusion Criteria:
- HLA matched donor (matching at 8/8 antigens or alleles including HLA A, B, C, and -DRB1).
- ≥ 18 years to 3.5 x 109/L
- Platelets > 150 x 109/L
- Hematocrit > 35%
- Capable of undergoing leukapheresis
- Able to understand and sign informed consent
Donor Exclusion Criteria:
- Psychological traits or psychological or medical conditions which make them unlikely to tolerate the procedure
- Pregnant or lactating female
Data sourced from ClinicalTrials.gov (NCT04151706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.