EUCTR2016-000227-71-BE进行中（未招募）1 期
A phase I/II study of Inotuzumab Ozogamicin as a single agent and incombination with chemotherapy for pediatric CD22-positiverelapsed/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
入排标准
- 性别
- All
入选标准
- •Eligibility:
- •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/1B-ASP 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 relapse
- •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
- •resolution of all such non-hematologic toxicities to = Grade 2 per the CTCAE 4.03.
- •Chemotherapy: At least 7 days wash-out; except for hydroxyurea, 6-mp and steroids (wash-out 48 hrs) and intrathecal therapy (no wash-out).
- •Patients who relapse while receiving maintenance chemotherapy will not be required to have a waiting period.
- •Radiotherapy: At least 28 days must have elapsed since any prior radiation therapy.
- •Hematopoietic Stem Cell Transplant: At least 90 days must have relapsed since previous allo-HSCT. No evidence of active GVHD; not
- •receiving GVHD prophylaxis or treatment.
- •Hematopoietic growth factors: At least 7 days wash-out of therapy with GCSF or other growth factors. At least 14 days wash-out of pegfilgrastim
- •(Neulasta®).
- •Immunotherapy: At least 42 days wash-out of any type of immunotherapy, e.g. CART therapy. No prior CD22-targeted therapy or
- •tumor vaccines permitted.
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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