Phase 2
Completed N=20
In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis
Source: ClinicalTrials.gov NCT01927120 ↗Enrolled (actual)
20
Serious AEs
55.0%
Results posted
Jul 2017
Primary outcomePrimary: Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT — 23.8 percentage of CD4+Tregs
Summary
IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus host disease (GVHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT |
23.8 | — |
| SECONDARY Overall Survival at Day +365 |
77.1 | — |
| SECONDARY Cumulative Incidence of Relapse |
35.2 | — |
| SECONDARY Cumulative Incidence of Grade II-IV Acute GVHD by Day +100 |
40 | — |
| SECONDARY Cumulative Incidence of Chronic GVHD by Day +365 |
61.5 | — |
| SECONDARY Incidence of Non-relapse Death |
5.0 | — |
| SECONDARY Incidence of Unexpected or Serious Adverse Events (AEs) |
2; 1; 1; 1; 3; 1 | — |
| SECONDARY Proportion of Treg Among Blood CD4+ T Cells at Day +90 After HCT |
0.212 | — |
| SECONDARY STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 30 |
34.1; 97.1; 19.3 | — |
| SECONDARY STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 90 |
20.2; 78.6; 16.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft.
- Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, or myeloproliferative neoplasms requiring a matched allogeneic HSCT.
- Acute Leukemia (AML or ALL) must be in complete remission defined as: 20% cellular, and peripheral absolute neutrophil count >1000/µL (platelet recovery is not required).
- Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have 4
Data sourced from ClinicalTrials.gov (NCT01927120). 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. Informational only — not medical advice.