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

AML Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• CML
• MDS

• NCT number: NCT00684008
• Study type: Interventional
• Source: Cytheris, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: March 2008
• Completion date: April 2011