Phase 2
Completed N=1
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II
Source: ClinicalTrials.gov NCT03941769 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities — 0 Participants
Summary
This phase I/II trial studies side effects and best dose of recombinant interleukin-7 in promoting immune cell recovery in patients with acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, or myeloproliferative disease after a haploidentical or cord blood stem cell transplant. A haploidentical transplant is a transplant that uses stem cells from a donor that is partially (at least 50%) matched to the patient. Umbilical cord blood is a source of blood-forming cells that can be used for transplant, also known as a graft. However, there is a small number of blood-forming cells available in the transplant, which may delay the "take" of the graft in the recipient. Recombinant interleukin-7 may affect the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, natural killer cells, and B cells) in patients who have had a haploidentical or cord blood stem cell transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities |
— | — |
| SECONDARY Overall Survival |
— | — |
Eligibility Criteria
Inclusion Criteria
- English and non-English speaking patients are eligible.
- Patient post a cord blood transplant (CBT) or haplo-SCT, with matched unrelated donors (MUDs), both peripheral blood (PB) and marrow sources with documented absolute neutrophil engraftment
- Patients with documented engraftment but require granulocyte-colony stimulating factor (G-CSF) to treat myelosuppression induced by drugs used to treat or prevent infection are eligible
- Karnofsky performance status (KPS) > 60%
- Absence of dyspnea or hypoxia ( 60 mL/min/1.73 m^2
- Diagnosis of acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid leukemia; myelofibrosis or myeloproliferative disease
Exclusion Criteria
- Pregnant or nursing
- History of lymphoid malignancy (including Hodgkin disease, non-Hodgkin lymphoma, acute lymphoblastic leukemia and chronic lymphocytic leukemia) or acute biphenotypic leukemia
- Patients with acute GVHD > grade 2 at any time during the post-transplant course
- Ongoing immunosuppressive therapy for the treatment of GVHD. Patients receiving GVHD prophylaxis will be allowed on this study
- History of Epstein-Barr virus (EBV) associated lymphoproliferation
- Active uncontrolled viral, bacterial or fungal infection
- History of autoimmune disease
- Receiving systemic corticosteroid therapy, budesonide is allowed
- Uncontrolled hypertension
- Corrected QT (QTc) prolongation (QTc > 470 ms) or prior history of significant arrhythmia or electrocardiogram (ECG) abnormalities
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Patients with cognitive impairments and/or any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent
Data sourced from ClinicalTrials.gov (NCT03941769). 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.