EUCTR2016-000227-71-DE进行中（未招募）1 期
A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia - ITCC-059
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age for all strata (Str1A, ph2, Str1B, Str2 and Str3): Patients must be =
- •1 and < 18 years of age
- •Patients with Down syndrome are excluded in Stratum 1A and 1B/1BASP
- •but not in the phase 2 cohort and Stratum 3
- •Additional criteria for Stratum 1A and 1B:
- •First 3 patients on dose level 1 must be 6-18 yrs.
- •Then at least 2 additional patients must be enrolled from age 1-6 yrs at
- •the same dose level.
- •After this: subsequent dose levels may enroll patients aged 1-18 yrs.
- •In case 2 younger patients are not yet recruited, patients aged 6-18yrs
- •may continue to be enrolled at dose level 1 until a maximum of 6
- •patients are enrolled.
- •Stratum 1A, phase 2 and stratum 1B/1B-ASP: Diagnosis
- •Patients must have either 1st relapsed BCP-ALL after allo-HSCT or 2nd or
- •greater relapsed or refractory BCP-ALL, or refractory disease (after at
- •least 2 prior regimens):
- •M2 or M3 marrow status (= 5% blasts by morphology)
- •CD22 surface antigen positive (either BM or PB)
- •Stratum 1 only: The first 6 patients must have M3 marrow status (=
- •25% blasts by morphology).
- •Stratum 2: Diagnosis
- •Patients must have 2nd or greater relapsed or refractory CD22-positive
- •B-cell malignancy including but not limited to diffuse large B-cell
- •lymphoma (DLBCL), primary mediastinal large B-cell lymphoma
- •(PMBCL), Burkitt lymphoma, Burkitt leukemia or B-cell precursor
- •lymphoblastic lymphoma:
- •Histologic verification of disease at original diagnosis or subsequent
- •Evaluable or measurable disease (by radiographic criteria or BM
- •disease present)
- •CD22 surface antigen positive (either biopsy material, BM or PB)
- •Str3: diagnosis:
- •1st BM or combined relapse of CD22+ VHR BCP-ALL defined as:
- •- any relapse <18 months from initial diagnosis and/or
- •- cytogenetic-high risk characteristics: KTM2A/AF4, E2A/TCF3-PBX1
- •t(1;19) or E2A/TCF3-HLF t(17;19), hypodiploidy (less than 40
- •chromosomes), TP53 mutation and/or deletion
- •excluding patients transplanted in 1st CR.
- •M2 or M3 marrow status (= 5% blasts by morphology)
- •CD22 surface antigen positive (in either the BM or PB)
- •Evidence of prior fusion gene abnormalities is acceptable
- •cytogenetic-high risk characteristics determined by chromosome
- •banding analysis (CBA), FISH, PCR and/or Next Generation Sequencing
- •All strata:
- •Performance Level and Life Expectancy:
- •Karnofsky > 60% for patients > 16 years of age and Lansky > 60% for
- •patients = 16 years of age.
- •life expectancy of at least 6 weeks.
- •Prior Therapy:
- •Patients must have fully recovered from the acute toxic effects of all
- •prior chemotherapy, immunotherapy, or radiotherapy defined as
- 另有 18 项未显示
排除标准
- •Isolated extramedullary relapse:
- •Patients with isolated extramedullary disease are excluded (not applicable to lymphoma patients except for isolated CNS-relapse)
- •Patients with any history of prior or ongoing VOD/SOS per the modified Seattle criteria are excluded, as specified in appendix 3, or prior liver-failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of =1.5)].
- •Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient may not have:
- •A requirement for vasopressors;
- •Positive blood culture within 48 hours of study enrollment;
- •Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.
- •A positive fungal culture within 30 days of study enrollment.
- •Active fungal, viral, bacterial, or protozoal infection requiring IV or oral treatment. Chronic prophylaxis therapy to prevent infections is allowed.
- •Other anti-cancer therapy:
- •Patients will be excluded if there is a plan to administer non-protocol anti-cancer therapy including but not limited to chemotherapy, radiation therapy, or immunotherapy during the study period.
- •Allergic reaction:
- •Patients with prior Grade 3/4 allergic reaction to a monoclonal antibody are excluded.
- •Concurrent disease:
- •Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, interfere with consent, study participation, follow up, or interpretation of study results.
- •Patients with Down syndrome are excluded in the dose finding
- •parts (stratum 1A and 1B), but not in the phase 2 cohort or VHR cohort.
- •Additional exclusion criteria for Stratum 1B
- •Patients with grade 3-4 peripheral neuropathy (as defined in the Delphi consensus of acute toxic effects for childhood ALL by Schmiegelow et al.1 ). Patients with prior history of thrombosis during steroid and/or asparaginase are eligible provided they use adequate anti-coagulant prophylaxis, according to institutional guidelines.
- •Patients in whom prior experience suggests that a timely delivery of therapy is unlikely or associated with an undue risk because of intolerance.
- •Additional exclusion criteria for Stratum 1B-ASP cohort only
- •Patients with any history of PEG-asparaginase intolerance due to allergic reactions or silent inactivation during prior treatment.
- •Patients with any history of prior asparaginase-associated acute pancreatitis (any grade as defined in the Delphi consensus.1).
- •Patients who are excluded from Stratum 1B-ASP may potentially be enrolled in Stratum 1B expansion cohort.
- •Additional exclusion criteria for Stratum 3 (VHR cohort) only:
- •Patients who are transplanted in CR1 (such patients are eligible for
- •the phase 1B cohort).
研究者
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