Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Toxicity of Recombinant Human Interleukin-7 (CYT107) defined as any of the events grade 3 or 4 GVHD, secondary graft failure, death, or grade 4 organ failure
研究概览
简要总结
Participant is being asked to take part in this study because participant received an umbilical cord blood transplant as part of participant's standard treatment. Umbilical cord blood is a source of blood-forming cells that can be used for transplantation, also known as a graft.
The problem with this type of transplant is the small number of blood-forming cells available in cord blood transplants, which may delay the "take" of the graft in the transplant recipient.
There are 2 parts to this study.
The goal of Part 1 of this clinical research study is to learn if it is safe and practical to give recombinant human interleukin-7 (CYT107) to patients who have received a cord blood transplant. Researchers want to learn if CYT107 affects the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, NK cells, and B cells) in patients who have had a cord blood transplant.
The goal of Part 2 of this study is to learn if CYT107 may prevent or reduce the effects of graft-versus host disease (GVHD) or the likelihood of developing infections (such as cytomegalovirus [CMV], Epstein-Barr virus [EBV], and BK virus). GVHD happens when transplanted donor tissue attacks the tissues of the recipient's body.
This is an investigational study. CYT107 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how CYT107 is designed to work.
Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
Study Groups:
If participant is found to be eligible to take part in this study and participant agrees, participant will be assigned to a study group based on when participant joined this study.
In Part 1 of the study, 3 dose levels of CYT107 will be tested in this study. Up to 3 participants will be enrolled in each dose level. The first group of participants will receive the lowest dose level. The next group will receive a higher dose than the first group, if no intolerable side effects were seen. The third group will receive an even higher dose than the second, if no intolerable side effects were seen. Based on the results seen, 1 of the 3 doses will be selected as the recommended dose.
In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at the recommended dose found in Part 1.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years old or older.
- •Patient post a cord blood transplant (CBT) with documented absolute neutrophil engraftment and no evidence of GVHD or no history of acute or chronic GVHD requiring systemic steroids.
- •Patients with documented engraftment but require granulocyte colony-stimulating factor (G-CSF) for myelosuppressive antibiotics or antiviral medications are eligible.
- •Karnofsky performance status (KPS) > 60%.
- •Adequate organ function: Pulmonary: Absence of dyspnea or hypoxia (< 90% of saturation by pulse oximetry 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 m
- •Diagnosis of acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid leukemia or myeloproliferative disease.
排除标准
- •Pregnant or nursing.
- •History of lymphoid malignancy (including Hodgkin disease, non-Hodgkin lymphoma, Acute Lymphoblastic Leukemia and Chronic Lymphocytic Leukemia) or acute biphenotypic leukemia.
- •History of EBV associated lymphoproliferation.
- •Active uncontrolled viral, bacterial or fungal infection.
- •Documented human immunodeficiency virus (HIV)-1 or -2, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection at any time before or after transplant. (a positive hepatitis B serology indicative of a previous immunization is not an exclusion criteria).
- •EBV viremia equal to or greater than 500 copies EBV DNA/mL of blood by quantitative PCR.
- •History of autoimmune disease.
- •Receiving systemic corticosteroid therapy.
- •Receiving concurrent treatment with another investigational drug and/or biological agent.
- •Receiving anticoagulant therapy.
- •Uncontrolled hypertension.
- •QTc prolongation (QTc > 470 ms) or prior history of significant arrhythmia or ECG abnormalities.
- •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.
研究组 & 干预措施
Phase 1: Recombinant Human Interleukin-7 (CYT107)
In Part 1 of the study, 3 dose levels of CYT107 will be tested in this study. Up to 3 participants will be enrolled in each dose level. The first group of participants will receive the lowest dose level. The next group will receive a higher dose than the first group, if no intolerable side effects were seen. The third group will receive an even higher dose than the second, if no intolerable side effects were seen. Based on the results seen, 1 of the 3 doses will be selected as the recommended dose.
In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at the recommended dose found in Part 1.
干预措施: CYT107 (Drug)
Phase 2: Recombinant Human Interleukin-7 (CYT107)
In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at the recommended dose found in Part 1.
干预措施: CYT107 (Drug)
结局指标
主要结局
Toxicity of Recombinant Human Interleukin-7 (CYT107) defined as any of the events grade 3 or 4 GVHD, secondary graft failure, death, or grade 4 organ failure
时间窗: Within 42 days of the first injection
Effects of Patient Covariates Variables on the Immune Reconstitution Parameters
时间窗: Baseline up to 1 year post-IL-7
Longitudinal Bayesian model used to assess the effects of patient covariates variables on the immune reconstitution parameters.
Rate of Viral Infections in CBT Patients Who Received Three Doses of CYT107 Following Engraftment
时间窗: 3 weeks
The observed rates of virus infections evaluated by tabulation and Bayesian regression modeling.
次要结局
- Secondary Graft Failure(After CYT107 given up to one year)
- Effects of Patient Treatment Variables on the Immune Reconstitution Parameters(Baseline up to 1 year post-IL-7)