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Sponsored by: |
Cytheris, Inc. |
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Information provided by: | Cytheris, Inc. |
ClinicalTrials.gov Identifier: | NCT00684008 |
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 | Intervention | Phase |
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AML CML MDS |
Drug: CYT107 - Recombinant glycosylated human interleukin 7. Drug: rhIL-7 (CYT107) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
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.
Drug: rhIL-7 (CYT107)
10, 20, or 30 mcg/kg once a week for 3 consecutive weeks via the subcutaneous route.
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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:
Secondary Objectives:
To achieve preliminary characterization:
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient included in at least one of the following categories:
Adequate organ function:
Exclusion Criteria:
Contact: Miguel A Perales, MD | 212-639-8682 | peralesm@mskcc.org |
Contact: Karima Yataghene, MD | 212-639-8108 | yataghek@MSKCC.ORG |
United States, New York | |
Memorial Sloan-Kettering Cancer Institute | Recruiting |
New York, New York, United States, 10065 | |
Contact: Miguel A Perales, MD 212-639-8682 peralesm@mskcc.org | |
Contact: Karima Yatagehne, MD 212-639-8108 yataghek@mskcc.org | |
Principal Investigator: Marcel van den Brink, MD |
Principal Investigator: | Marcel van den Brink, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Marcel R.M. van den Brink, M.D., Ph.D. ) |
Study ID Numbers: | CLI-107-08, MSKCC IRB #07-127 |
Study First Received: | May 21, 2008 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00684008 |
Health Authority: | United States: Food and Drug Administration |
interleukin-7 immune based therapies graft vs host disease immune reconstitution infection |
lymphopenia hematopoetic stem cell transplantation bone marrow transplantation peripheral blood stem cell transplant immunosuppression |
Graft versus host disease Lymphopenia Graft vs Host Disease Homologous wasting disease |