2024-514877-23-00招募中2 期
VENTOGRAFT study: A phase I-II study to assess venetoclax + azacitidine and donor lymphocyte infusion in patients with MDS or AML in relapse after allo hematopoietic stem cell transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 14
- 主要终点
- Phase I: To determine toxicity profile and safety of the combination
研究概览
简要总结
The objectives of this study are to assess the safety, and efficacy, of venetoclax in combination with AZA/DLI in patients with MDS and AML (myeloid neoplasms) in relapse after allogeneic hematopoietic stem cell transplantation. Phase I: -Assess the safety profile of venetoclax in combination with AZA/DLI -Determine the recommended Phase II dose (RPTD) Phase II: Determine the efficacy of venetoclax in combination with AZA/DLI
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Documented relapse of MDS or AML (with WBC < 15000/mm3) after allo-SCT
- •Patient is able to swallow capsules
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Patient must have adequate organ function as indicated by the following laboratory values: Serum creatinine < 2 mg/dl OR calculated creatinine clearance ≥ 30 mL/min for patients with creatinine levels > 1.5 x institutional ULN ; Serum total bilirubin ≤ 2.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels ≥ 2 mg/dL ; AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN ; Alkaline Phosphatase ≤ 5 x ULN (If > 2.5 x ULN, then liver fraction should be ≤ 2.5 x ULN)
- •Patient not refractory to platelet transfusions
- •Female subject of childbearing potential must practice at least one protocol specified method of birth control, starting on Study Day 1 through at least 30 days after the last dose of venetoclax or 6 months after the last dose of azacitidine
- •Male subjects sexually active with female partner(s) of childbearing potential, must agree from first dose of study drug(s) through at least 30 days after the last dose of venetoclax or 3 months after the last dose of azacitidine, whichever is later, to practice the protocol specified contraception
- •Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study
- •Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study
排除标准
- •Patient has active and uncontrolled infection
- •Patient has received growth factors such as erythropoietin alfa (EPO) or granulocyte colony-stimulating factor (G-CSF) or has received non cytotoxic agents (including low dose oral chemotherapy) in the 30 days before inclusion. In case of previous cytotoxic treatment, an interval of 3 months is required.
- •Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤ 10 mg/day prednisone during the 4 weeks prior to the start of the study drugs
- •Patients with clinical evidence of CNS leukemia
- •Patient has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drugs
- •Subject has received strong or moderate CYP3A inhibitors within 3 days prior to the first dose of study drug
- •Patient is unable to take and/or tolerate oral medications on a continuous basis
- •Patient is pregnant or breastfeeding within the projected duration of the study
- •Subject has a malabsorption syndrome or other condition that precludes an enteral route of administration
- •Absence of social security
- •Patient has active acute or chronic GVHD
- •Patient receives more than 1mg/kg/day prednisolone
- •Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance
- •Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug
- •Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy
- •Patient has clinically active hepatitis B or hepatitis C infection
- •Patient has a known allergy or hypersensitivity to any component of VENETOCLAX or AZA
- •Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 2 years or are considered by their physician to be at less than 30% risk of relapse
结局指标
主要结局
Phase I: To determine toxicity profile and safety of the combination
Phase I: To determine toxicity profile and safety of the combination
Phase II: Overall hematological response rate of venetoclax in combination with AZA/DLI. Response assessment will be performed for MDS according to IWG criteria and according to European LeukemiaNet criteria for AML.
Phase II: Overall hematological response rate of venetoclax in combination with AZA/DLI. Response assessment will be performed for MDS according to IWG criteria and according to European LeukemiaNet criteria for AML.
次要结局
- Toxicity as measured by NCI CTCAE 5.0
- Acute and chronic GVHD rate
- Duration of response
- Overall survival
- Progression-free survival
- Event-free survival
研究者
Thomas CLUZEAU
Scientific
Groupe Francophone Des Myelodysplasies
研究点 (14)
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