EUCTR2013-000706-36-IT
Active, not recruiting
Phase 1
A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study) - Alcantara Study
ConditionsAdult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALLMedDRA version: 16.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALL
- Sponsor
- Amgen Inc.
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with Ph\+ B\-precursor ALL, with any of the following:
- •Relapsed or refractory to at least one second generation TKI (dasatinib, nilotinib, bosutinib, ponatinib)
- •OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
- •2\. Greater than 5% blasts in bone marrow
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status \= 2
- •4\. Age \= 18 years of age, at the time of informed consent
- •5\. Subject has provided informed consent or subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. History of malignancy other than ALL within 5 years prior to start of protocol\-required therapy with the exception of:
- •\- Malignancy treated with curative intent and with no known active disease present for 5 years before enrollment and felt to be at low risk for recurrence by the treating physician
- •\- Adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease
- •\- Adequately treated cervical carcinoma in situ without evidence of disease
- •\- Adequately treated breast ductal carcinoma in situ without evidence of disease
- •\- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •2\. History or presence of clinically relevant CNS pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis
- •\- With the exception of CNS leukemia that is well controlled with intrathecal therapy
- •3\. Active ALL in the CNS (confirmed by CSF analysis) or testes (no clinical sign thereof)
- •4\. Isolated extramedullary disease
Outcomes
Primary Outcomes
Not specified
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