NL-OMON56001尚未招募2 期
Phase II trial of nivolumab for pediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of response in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2) - NIVO-ALC
Gustave Roussy0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2
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
- 年龄范围
- 0 至 64（—）
入选标准
- •I-1. Histologically confirmed evidence of relapsed/refractory ALK+ ALCL. If
- •biopsy could not be performed, relapsed/refractory status should be confirmed
- •by molecular analysis whenever possible (increase of MRD quantitative PCR at 2
- •consecutive measures qualifying for a significant increase according to the
- •same reference laboratory, with clinical signs and symptoms suggestive of
- •progressing disease). In this case, relapsed/refractory status must be reviewed
- •and confirmed by the international coordinating investigator.
- •I-2. Age at inclusion > 6 months
- •I-3. No washout needed, but patients must have recovered from acute toxic
- •effects of all prior therapy before enrollment into the study. A short course
- •of steroids is allowed at the beginning of Nivolumab if it is clinical
- •I-4. Adequate organ function:
- •* Peripheral absolute neutrophil count (ANC) >=750/µL in patients without bone
- •marrow involvement and >=500/µL in patients with bone marrow involvement
- •(unsupported)
- •* Platelet count >=75,000/µL in patients without bone marrow involvement and 50
- •000 in patients with bone marrow involvement (unsupported)
- •* Hemoglobin >=8.0 g/dL (transfusion is allowed)
- •* Serum creatinine <=1.5 x upper limit of normal (ULN) for age
- •* Total bilirubin <=1.5 x ULN in patients without liver involvement and < 2.5
- •ULN in patients with liver involvment
- •* Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) <=3
- •x ULN in patients without liver involvement and < 5 ULN in patients with liver
- •involvement
- •* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase/SGOT
- •<=3 x ULN in patients without liver involvement and < 5 ULN in patients with
- •liver involvment
- •I-5. Performance status: Karnofsky performance status (for patients >12 years
- •of age) or Lansky Play score (for patients <=12 years of age) >= 40%.
- •I-6. Able to comply with the scheduled disease management (treatment and
- •follow-up), and with the management of toxicity
- •I-7. Females of childbearing potential must have a negative serum β-HCG
- •pregnancy test within 24 hours prior to initiation of treatment. Sexually
- •active women of childbearing potential must agree to use acceptable and
- •appropriate contraception during the study and for at least 5 months after
- •the last study treatment administration. Sexually active males patients must
- •agree to use condom during the study and for at least 7 months after the last
- •study treatment administration. Acceptable contraception is listed in Appendix
- •I-8. Written informed consent from parents/legal representative, patient, and
- •age-appropriate assent before any study-specific screening procedures are
- •conducted according to local, regional or national guidelines.
- •I-9. Patient affiliated to a social security regimen or beneficiary of the same
- •according to local requirements.
- •I-10. Patients will prior allogeneic HSCT may be included if clinically
- •indicated (see non-inclusion criteria regarding prior allogeneic HSCT). In this
- •case, study inclusion must be confirmed by the international coordinating
- •investigator.
- •For being enrolled in Cohort 1, all criteria from C1.I-1 to C1.I-2 are
- •required, in addition of I-1 to I-10 criteria
- •C1.I-1. Measurable progressive disease with at least one lesion measuring more
- 另有 1 项未显示
排除标准
- •E-1. Patients with prior allogeneic HSCT less than 3 months before study
- •E-2. Patients with prior allogeneic HSCT and any active graft versus host
- •disease (GVHD) and/or any prior grade 3 or 4 GVHD according to International
- •Bone Marrow Transplant Registry (ITBMR)
- •E-3. Previous organ transplantation
- •E-4. Significant hemophagocytosis in bone marrow, spleen, lymph nodes, or liver
- •must be discussed with the Coordinating Sponsor before inclusion
- •E-5. Presence of any >= CTCAE grade 2 treatment-related toxicity with the
- •exception of alopecia, fatigue and peripheral neuropathy.
- •E-6. History or evidence of severe uncontrolled illness that contra-indicates
- •use of an investigational drug, or places the patient at unacceptable risk from
- •treatment complications
- •E-7. History or evidence of severe acute or chronic infection unless fully
- •healed at least four weeks prior to screening
- •E-8. Known human immunodeficiency virus (HIV) infection
- •E-9. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis
- •C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- •E-10. History or evidence of any auto-immune disease. Subjects with vitiligo,
- •type I diabetes mellitus, residual hypothyroidism due to autoimmune condition
- •only requiring hormone replacement, psoriasis not requiring systemic treatment,
- •or conditions not expected to recur in the absence of
- •an external trigger are permitted to enroll.
- •E-11. Subjects with another pathology requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalents) or other
- •immunosuppressive medications within 14 days of study drug administration.
- •Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily
- •prednisone equivalents are permitted in the absence of active autoimmune
- •E-12. Known hypersensitivity to any component of the products (study drug or
- •ingredients)
- •E-13. Concurrent administration of any other antitumor therapy
- •E-14. Clinically significant, uncontrolled heart disease (including history of
- •any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal
- •arrhythmias, or conduction abnormality within 12 months of screening).
- •E-15. Vaccinated with live attenuated vaccines within 4 weeks of the first dose
- •of the study drug
- •E-16. Pregnant or breast-feeding female patient
- •E-17. Patient under guardianship or deprived of his liberty by a judicial or
- •administrative decision, patients under safeguards of justice or incapable of
- •giving its consent, patients undergoing psychiatric care under duress
- •E-18. Participation in another clinical study with an investigational product
- •during the study
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