Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00684008|
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : July 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|AML CML MDS||Drug: CYT107 - Recombinant glycosylated human interleukin 7. Drug: rhIL-7 (CYT107)||Phase 1|
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.
- 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).
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2008|
|Actual Study Completion Date :||April 2011|
Single arm dose escalation study. Three successive cohorts of 3 patients each. Doses to be evaluated: 10, 20, and 30 mcg/kg/dose for 3 consecutive doses.
CYT107 is a recombinant protein belonging to the class of growth factors known as cytokines.
CYT107 is a heavily glycosylated and sialylated form of recombinant human Interleukin-7.
CYT107 is supplied as a sterile colorless liquid at a concentration of 4 mg/ml.
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.
Other Name: rhIL-7
Drug: rhIL-7 (CYT107)
10, 20, or 30 mcg/kg once a week for 3 consecutive weeks via the subcutaneous route.
Other Name: interleukin-7
- Toxicity of CYT107 in post-transplant patients with AML, CML and MDS using the NCI Common Toxicity Criteria version 3.0 with the BMT specific adverse event grading system. [ Time Frame: Visits: 2 week screening period; treatment visits on days 0, 7, and 14; non-treatment visits on Days 1, 21, 28, 42, 56, and 77. ]
- Pharmacokinetics and Pharmacodynamics [ Time Frame: Study days 0, 1, 7, 14, 21, 28, 42, and 77. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684008
|United States, New York|
|Memorial Sloan-Kettering Cancer Institute|
|New York, New York, United States, 10065|
|Principal Investigator:||Marcel van den Brink, MD, PhD||Memorial Sloan Kettering Cancer Center|