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A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

Disease Information

Descriptive Information
Brief Title † A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance
Official Title † A Pilot Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance
Brief Summary The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia [ALL], Non-Hodgkin's Lymphoma [NHL]).
Detailed Description
Study Phase Early Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Overall survival at two years post first treatment cycle
Secondary Outcome Measure † Non-Relapse Mortality
Condition † Acute Lymphoblastic Leukemia B-cell Non Hodgkin Lymphoma Pre B-Cell Acute Lymphoblastic Leukaemia
Intervention † DrugBlinatumomab
Study Arms / Comparison Groups Post-alloHSCT Maintenance Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 12
Start Date † May 2017
Completion Date May 2020
Primary Completion Date May 2020
Eligibility Criteria † Inclusion Criteria: - Pre-B ALL, low and high grade NHL who underwent an alloHSCT using posttransplant CY GVHD prophylaxis (Pt-Cy alone or combination with MMF/tacrolimus or sirolimus) as follows: - Pre-B ALL patients in CR1 with high-risk features such as adverse cytogenetics including t(9;22), t(4;11) or other MLL rearrangements, t(8;14), complex karyotype (≥5 chromosomal abnormalities), hypodiploidy (1 x109/L, and non-transfused platelets >30x109/L) and no evidence of disease progression - ECOG performance status 0-2 - Ability to give informed consent - In agreement to use an effective barrier method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile - Age ≥18 years - Patients may have received any number of prior regimens to achieve remission. Patients previously treated with blinatumomab will be eligible as long as they did not experience unacceptable toxicities with prior blinatumomab administration. If patient was refractory (no response) to blinatumomab in the past, patient will be eligible if there was no evidence of CD19 loss on leukemia cells. Exclusion Criteria: - Lack of engraftment (less than 85% donor DNA in bone marrow or peripheral blood after allogeneic HSCT). - Active or untreated disease in central nervous system or testes - Patient has received chemotherapy or radiotherapy (with the exception of intrathecal chemotherapy) within 2 weeks of starting blinatumomab. Patient could receive intrathecal prophylactic chemotherapy within a week prior to starting blinatumomab. - Patients with active uncontrolled infection or uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Patients with active acute GVHD (grade 2-4) and active moderate or severe chronic GVHD with GVHD therapy initiation or escalation within 28 days. Patients who required steroids for the treatment of GVHD will need to be off steroids for at least 2 weeks before enrollment. (Topical steroids or physiologic adrenal replacement steroid doses are allowed). - Patients requiring calcineurin inhibitors (i.e. tacrolimus or sirolimus) or other systemic immunosuppressants (cyclosporine (CNI); methotrexate or similar) for GVHD prophylaxis or treatment within 2 weeks prior to study enrollment. - Inadequate end organ function defined as AST, ALT, and alkaline phosphatase > 3X ULN, bilirubin >=1.5X ULN, or creatinine >=2 mg/dL - Patients with Ph-positive ALL who are eligible for post-transplant TKI maintenance based on a demonstrated sensitivity to TKIs pre-transplant (patients with known intolerance or resistance to TKI will be eligible) - Evidence of progressive disease post-transplant - Women who are pregnant or lactating - Known hypersensitivity to blinatumomab - Patients with a concurrent active malignancy for which they are receiving treatment - Concurrent use of any other investigational drugs - Patient who have a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, psychosis, or other significant CNS abnormalities. A history of treated CNS leukemia or lymphoma will be allowed if recent imaging and CSF studies confirm the absence of active CNS disease at the time of study entry - Weight
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Ivana Gojo, MD, 410-502-8775, igojo1@jhmi.edu
Location Countries † United States
Administrative Information
NCT ID † NCT03114865
Organization ID J1713
Secondary IDs †† IRB00125679
Responsible Party Sponsor
Study Sponsor † Sidney Kimmel Comprehensive Cancer Center
Collaborators ††
Investigators † Principal Investigator: Ivana Gojo, MD, Johns Hopkins University
Information Provided By
Verification Date April 2017
First Received Date † April 11, 2017
Last Updated Date April 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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