NCT00684008

Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant

A Phase I Study of CYT107 (Recombinant Glycosylated Human IL-7) in Recipients of HLA Matched Ex Vivo T Cell Depleted Bone Marrow or Peripheral Blood Stem Cell Transplant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cytheris, Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral blood stem transplants. The dose escalation design is aimed at establishing the absence of significant toxicity and to define a biologically active dose in this patient population. At each dose level, eligible patients will receive 3 doses of CYT107 injected subcutaneously (under the skin of the arm, legs, or stomach) once a week for 3 weeks. Groups of three patients will be entered at each dose level of CYT107. Three dose levels are planned: 10 mcg/kg/week, 20 mcg/kg/week and 30 mcg/kg/week. Three patients must complete day 42 of the study at a dose level without a dose limiting toxicity (DLT) before there is escalation to the next dose level.

Detailed description

Rationale: Delayed and deficient reconstitution of T cells and their functions are a major obstacle to the success of a hematopoietic stem cell transplant (HSCT). CYT-107 may have potential clinical use after allogeneic HSCT to enhance lymphoid reconstitution which could have a number of beneficial effects including decreased morbidity and mortality from post-transplant infections. Our preliminary data with a previous generation IL-7, CYT 99 007, raise the possibility that IL-7 could have, in some cases, an anti-GVHD effect while keeping the anti-tumor effect of the allograft intact. Primary Objective: * To determine the safety and a recommended dose of CYT107 (r-hIL-7) in recipients of an HLA-matched related or unrelated ex vivo T-cell-depleted bone marrow (BM) or peripheral blood stem cell (PBSC) transplant after initial engraftment and hematopoietic reconstitution. * If toxicities are encountered, to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT). Secondary Objectives: * To define the pharmacokinetics of escalating doses of CYT107 in recipients of allogeneic transplants. To achieve preliminary characterization: * Of the effects of CYT107 treatment on engraftment and GVHD. * Of the effects of CYT107 on the recovery of T, NK and B cell populations and their functions in vitro. * Of a tolerable biologically active range of doses for CYT107 in recipients of allogeneic transplants. * Whether and to what degree administration of CYT107 might influence the risk of developing an EBV-lymphoproliferative disorder. * Of the effects of CYT107 treatment on leukemia relapse.

Conditions

• AML
• CML
• MDS

Interventions

Type	Name	Description
DRUG	CYT107 - Recombinant glycosylated human interleukin 7.	Patients will be treated with CYT107 60 to 210 days post transplantation, in 3 successive cohorts of 3 patients. Escalating doses of CYT107 will be given to successive cohorts. Patients will receive 1 dose of CYT107 by the subcutaneous route, once a week for 3 weeks. Dose level 1: 10 mcg/kg/dose for 3 doses; Dose level II: 20 mcg/kg/dose for 3 doses; Dose level III: 30 mcg/kg/dose for 3 doses. Only 1 treatment course for this initial study.
DRUG	rhIL-7 (CYT107)	10, 20, or 30 mcg/kg once a week for 3 consecutive weeks via the subcutaneous route.

Timeline

• Start date: 2008-03-01
• Completion: 2011-04-01
• First posted: 2008-05-26
• Last updated: 2012-07-26

Locations

1 site across 1 country: United States