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

Completed · Phase 1

Conditions studied: AML, CML, MDS

In brief

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.

Key facts

Study ID

NCT00684008

Run by

Cytheris, Inc.

People needed

12

Starts

2008-03-01

Expected to finish

2011-04-01

Last updated by the study team

2012-07-26

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read consent form and give informed consent.
• At least 15 years old.
• Histologically confirmed non-lymphoid hematological malignancy.
• Recipient of T cell depleted bone marrow (BM) or peripheral blood stem cell (PBSC) transplant from a 6/6 HLA (A, B, DR by intermediate resolution) identical related or unrelated donor after myeloablative conditioning.
• Received TCD HCT containing < 1x105 CD3+ T cells/kg of recipient.
• Patient included in at least one of the following categories:
• AML in 2nd or greater complete remission.
• High-risk AML (high-risk cytogenetics, undifferentiated leukemia, secondary AML, antecedent MDS) in 1st remission.
• CML in 2nd or greater chronic phase, 2nd or greater accelerated phase.
• MDS intermediate or high risk by IPSS criteria.
• History of opportunistic infection (CMV viremia requiring anti-viral therapy, PCP pneumonia, mycobacterial infection, herpes zoster, viral respiratory infection (influenza, RSV, para-influenza), etc.
• CD4+ T cell count < 100 at 6 months post-transplant.
• At high risk for opportunistic infection (e.g., history of treated invasive fungal infection prior to the transplantation, positive CMV serology in patient, or positive toxoplasmosis serology in donor and patient, etc.).
• 60 - 210 days post transplant.
• In remission at the time of initiation of CYT107.
• Documented engraftment with sustained neutrophil counts of at least 1000/mcl and untransfused platelet counts > 20 000/mcl for 3 consecutive lab values (the last one tested <10 days before initiation of treatment) on 3 different days prior to treatment. Patients who have engrafted but require G-CSF for myelosuppressive antibiotics or antiviral medications are eligible if they require G-CSF no more than twice weekly and their ANC remains >1000/mcl.
• KPS > 60%.
• Adequate organ function:
• Cardiac: No evidence of change in cardiac function by history, exam and/or EKG post-HCT.
• Pulmonary: Absence of dyspnea or hypoxia (< 90% of saturation by pulse oxymetry on room air).
• Hepatic: Bilirubin <= 1.5 X ULN, AST (SGOT) and /or ALT (SGPT) <= 2.5 X ULN. PT/PTT < 1.5 X ULN.
• Renal: Calculated Creatinine clearance > 60 mL/min/1.73 m2. [Note: all transplant patients had an ejection fraction of > 40% on their pre-transplant echocardiogram and a DLCO > 50% of predicted (corrected for hemoglobin)]

You may not qualify if…

• No evidence or history of acute GVHD or of chronic GVHD.
• No recurrent leukemia post HCT.
• No active uncontrolled viral, bacterial or fungal infection.
• No documented HIV-1 or -2, HBV or HCV infection at any time before or after transplant (a positive hepatitis B serology indicative of a previous immunization is not an exclusion criteria).
• Not be receiving systemic corticosteroid, anti-mitotic agent or other immunosuppressive treatment.
• Not receiving Growth Hormone or gonadotropin agonists/ antagonists.
• Not receiving any cytokine support other than G-CSF post-HCT.
• Not receiving concurrent treatment with another investigational drug and/or biological agent.
• Not receiving anticoagulant therapy.
• No uncontrolled hypertension.
• No history of lymphoid malignancy (e.g. Hodgkin disease, non Hodgkin lymphoma, Acute Lymphoblastic Leukemia and Chronic Lymphocytic Leukemia) or acute biphenotypic leukemia.
• No peripheral lymphadenopathy (any lymph node > 1 cm).
• No history of EBV associated lymphoproliferation.
• No EBV viremia equal to or greater than 500 copies EBV DNA/mL of blood by quantitative PCR.
• No history of autoimmune disease nor a HCT donor with a history of an autoimmune disease.
• Fertile patients must use effective birth control. Not pregnant or nursing. Negative pregnancy test within 2 weeks of study treatment.
• QTc prolongation (QTc > 470 ms) or prior history of significant arrhythmia or ECG abnormalities.
• No active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent.

Where it is running

• Memorial Sloan-Kettering Cancer Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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