Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Cord Blood Transplant Recipient
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the safety and establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of recombinant interleukin-7 (interleukin 7 [IL-7, CYT107]). SECONDARY OBJECTIVES: I. To determine the rate of cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK viral...
PRIMARY OBJECTIVES: I. To determine the safety and establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of recombinant interleukin-7 (interleukin 7 [IL-7, CYT107]). SECONDARY OBJECTIVES: I. To determine the rate of cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK viral infections in cord blood transplant (CBT) patients who receive three doses of 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. IV. To obtain information about the pharmacokinetic (PK) profile of CYT107 by estimating time to maximum concentration (Tmax), concentration maximum (Cmax), half-life, clearance and area-under-the-curve (AUC). 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.
Tracking Information
- NCT #
- NCT03941769
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Gheath Al-Atrash M.D. Anderson Cancer Center