EUCTR2014-001700-21-DE
Active, not recruiting
Phase 1
An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Rialto Study) - Rialto Study
DrugsBlincyto
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amgen Inc.
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Immunophenotypic evidence of CD19 positive B\-precursor ALL (pro B\-, pre B\-, common ALL)
- •2\. Age \> 28 days and \< 18 years at the time of informed consent/assent
- •3\. Morphological or molecular evidence of relapsed/refractory disease, defined as one of the following:
- •Second or later bone marrow relapse (defined as M3 marrow or M2 marrow or M1 marrow but with an MRD level \= 10\-3\), or;
- •Any marrow relapse after alloHSCT (defined as M3 marrow or M2 marrow or M1 marrow but with an MRD level \= 10\-3\), or
- •Refractory to other treatments:
- •o For patients in first relapse: failure to achieve a CR following a full standard reinduction chemotherapy regimen
- •o For patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
- •Subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab (Note: This does not include patients who
- •have already received blinatumomab treatment on this study, but refers
Exclusion Criteria
- •1\. Any active acute Graft\-versus\-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
- •2\. Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids)
- •3\. Active (overt) ALL in the CNS (confirmed by cerebrospinal fluid \[CSF] analysis) or in testes
- •4\. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis
- •\- With the exception of CNS leukemia that is well controlled with intrathecal therapy
- •5\. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •6\. Cancer chemotherapy within 2 weeks prior to start of blinatumomab (except for tyrosine kinase inhibitors (TKI) and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids; intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab).
- •7\. Chemotherapy related toxicities that haven’t resolved to \= grade 2
- •8\. Radiotherapy within 4 weeks prior to blinatumomab treatment
- •9\. Immunotherapy (eg, rituximab) within 6 weeks prior to blinatumomab treatment
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Clinical Study with the bispecific antibody Blinatumomab in pediatric and adolescent subjects with B-precursor Acute Lymphoblastic Leukemia (ALL) who did not respond to previous therapy or who relapsed after initial successful previous therapyPediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)MedDRA version: 17.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10066109Term: Precursor B-lymphoblastic leukemia acuteSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-001700-21-ITAmgen Inc.110
Active, not recruiting
Phase 1
Clinical Study with the bispecific antibody Blinatumomab in pediatric and adolescent subjects with B-precursor Acute Lymphoblastic Leukemia (ALL) who did not respond to previous therapy or who relapsed after initial successful previous therapyPediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)MedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10066109Term: Precursor B-lymphoblastic leukemia acuteSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-001700-21-ATAmgen Inc.100
Active, not recruiting
Phase 1
Clinical Study with the bispecific antibody Blinatumomab in pediatric and adolescent subjects with B-precursor Acute Lymphoblastic Leukemia (ALL) who did not respond to previous therapy or who relapsed after initial successful previous therapyPediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)MedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10066109Term: Precursor B-lymphoblastic leukemia acuteSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-001700-21-GBAmgen Inc.110
Active, not recruiting
Phase 1
Clinical Study with the bispecific antibody Blinatumomab in pediatric and adolescent subjects with B-precursor Acute Lymphoblastic Leukemia (ALL) who did not respond to previous therapy or who relapsed after initial successful previous therapyPediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)MedDRA version: 17.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 17.1Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 17.1Level: LLTClassification code 10066109Term: Precursor B-lymphoblastic leukemia acuteSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-001700-21-FRAmgen Inc.110
Completed
Phase 4
A Global Expanded Access Program for Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (EV-902)JPRN-jRCT2031210099Steinberg Joyce350