A Phase I/II Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Haploidentical and Cord Blood Stem Cell Transplantation

2018-0674

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.

2020-09-29

2023-03-01

2023-03-01

Completed

Early phase I

1

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 (\< 90% of saturation by pulse oximetry on room air) * Bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN * Prothrombin time (PT)/partial prothrombin time (PTT) \< 1.5 x ULN * Calculated creatinine clearance \> 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

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2023-08-01