2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II

M.D. Anderson Cancer Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Myeloproliferative Neoplasm

Cord Blood Transplant Recipient

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Treatments

Biological: Recombinant Interleukin-7

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03941769

2018-0674 (Other Identifier)

NCI-2019-02124 (Registry Identifier)

R01CA061508 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine the safety and establish the optimal biologic dose of glycosylated recombinant human interleukin-7 (CYT107).

SECONDARY OBJECTIVES:

I. To determine the rate of cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK viral infections in umbilical cord blood stem cell transplantation (CBT) and haploidentical stem cell transplantation (haplo-SCT) patients who receive three doses of interleukin-7 (IL-7) following engraftment.

II. To calculate the overall survival (OS), progression-free survival (PFS), and cumulative incidence of graft versus host disease (GVHD) and cumulative incidence of relapse.

III. To evaluate the effects of CYT107 on the recovery of T, natural killer (NK) and B cell populations and their functions in vitro; these data will be used to identify the optimal dose to move to a phase II trial.

OUTLINE: This is a dose-escalation study.

Within 60-180 days after CBT, patients receive recombinant interleukin-7 intramuscularly (IM) or subcutaneously (SC) once per week for 3 weeks.

After completion of study treatment, patients are followed for up to 3 years.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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