PER-023-20招募中未知
OPEN-LABEL, SINGLE-ARM TRIAL TO EVALUATE ANTITUMOR ACTIVITY, SAFETY, AND PHARMACOKINETICS OF ISATUXIMAB USED IN COMBINATION WITH CHEMOTHERAPY IN PEDIATRIC PATIENTS FROM 28 DAYS TO LESS THAN 18 YEARS OF AGE WITH RELAPSED/REFRACTORY B OR T ACUTE LYMPHOBLASTIC LEUKEMIA OR ACUTE MYELOID LEUKEMIA IN FIRST OR SECOND RELAPSE
Sanofi Aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2020年9月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •INCLUSION CRITERIA
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participant must be 28 days to less than 18 years of age at the time of the signing of the
- •informed consent. Participants under 2 years of age can only be enrolled after the dose
- •reassessment is completed on the first 20 participants who are 2 to less than 18 years of
- •age (see Section 4.3 and Section 9.5).
- •02. Type of participant and disease characteristics
- •Participants must have a confirmed diagnosis of relapsed ALL of T- or B-cell origin
- •including lymphoblastic lymphoma (LBL, or relapsed AML (excluding M3 type: acute
- •promyelocytic leukemia) including participants with history of myelodysplasia (MDS).
- •A) Male participants: A male participant with a female partner of childbearing potential must
- •agree to use contraception as detailed in Appendix 4 (Section 10.4) of this protocol during
- •the treatment period and for at least 6 months after the last dose of isatuximab, or
- •12 months after the last dose of cyclophosphamide and refrain from donating sperm during
- •this period.
- •B) Female participants: A female participant is eligible to participate if she is not pregnant
- •(see Appendix 4 [Section 10.4]), not breastfeeding, and at least one of the following
- •conditions applies:
- •04. Informed Consent
- •The participant who has reached legal age of majority as defined by local regulation or the
- •parent(s)/legal guardian(s) must provide signed informed consent prior to any study-related
- •procedures being performed. If the participant is legally a minor per local regulations,
- •assent shall be obtained from the participant, if applicable.
排除标准
- •EXCLUSION CRITERIA
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical conditions
- •01. Evidence of ongoing infection or seropositivity for human immunodeficiency virus (HIV),
- •or active hepatitis B (defined as either positive hepatitis B surface [HBs] antigen or
- •positive hepatitis B viral deoxyribonucleic acid [DNA] test above the lower limit of
- •detection of the assay), or hepatitis C infection. Presence of positive hepatitis B core (HBc)
- •antibody in the presence of a negative HBs antigen test or a negative hepatitis B viral DNA
- •test in serum indicates a prior infection without currently active hepatitis or carrier status
- •and is not an exclusion criterion. Human immunodeficiency virus, hepatitis B, and
- •hepatitis C virus serology testing to be performed and collected in database only in
- •countries where requested by local regulations.
- •E 02. Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ
- •carcinoma, unless they are successfully treated with curative intent for more than 3 years
- •before entering the study.
- •E 03. Cardiomyopathy New York Heart Association Grade 3 or 4.
- •E 04. History of thrombophilic disease, allergic to asparaginase for participants with ALL, or
- •prior intolerance (ie, serious thrombosis, pancreatitis, or hemorrhagic events).
- •E 05. Eastern Cooperative Oncology Group (ECOG) performance status >2 or Lansky score <70
- •(see Section 10.6.2 and Section 10.6.3).
- •E 06. Total bilirubin >2.5 × upper limit of normal (ULN) unless the participant has
- •Gilbert’s syndrome or elevation related to acute leukemia.
- •E 07. Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >5 × ULN,
- •unless considered due to the disease.
- •E 08. Serum creatinine >2 × ULN and/or estimated glomerular filtration rate (eGFR)
- •<30 mL/min/1.73 m2 (by revised Schwartz equation, Section 10.6.4).
- •E 09. Any serious active disease or comorbid condition that, in the opinion of the Investigator,
- •may interfere with the safety of the study intervention or the compliance with the study
- •Prior/concomitant therapy
- •E 10. Participants must have been off prior treatment with immunotherapy/investigational agents
- •and chemotherapy for >2 weeks and must have recovered from acute toxicity (ie, to
- •Grade 1 or less except alopecia or peripheral neuropathy Grade ≤2 without pain) before the
- •first study intervention administration. The study treatment may start earlier if necessitated
- •by the participant´s medical condition (eg, rapidly progressive disease) following
- •discussion with the Sponsor.
- •E 11. Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus
- •Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week
- •before the first study intervention administration.
- •Prior/concurrent clinical study experience
- •E 12. Intolerance or contraindication to treatment with mAb or any other drug part of the study
- •intervention.
- •Other exclusion criteria are described in protocol section 5.2
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