OncoMatch/Clinical Trials/NCT02997761
Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
Is NCT02997761 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Blinatumomab and Ibrutinib for adult b acute lymphoblastic leukemia.
Treatment: Blinatumomab · Ibrutinib — This phase II trial studies how well ibrutinib and blinatumomab work in treating patients with B acute lymphoblastic leukemia that has come back or is not responding to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating patients with relapsed or refractory B acute lymphoblastic leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Allowed: BCR fusion with ABL1 (Philadelphia chromosome-positive)
Philadelphia chromosome-positive (Ph+) B-ALL patients must have failed treatment with at least one second generation tyrosine kinase inhibitor
Disease stage
Required: Stage RELAPSED, REFRACTORY
Prior therapy
Must have received: second generation BCR-ABL inhibitor — Philadelphia chromosome-positive (Ph+) B-ALL only
Philadelphia chromosome-positive (Ph+) B-ALL patients must have failed treatment with at least one second generation tyrosine kinase inhibitor
Cannot have received: ibrutinib (ibrutinib)
History of treatment with ibrutinib
Cannot have received: blinatumomab (blinatumomab)
History of treatment with blinatumomab
Cannot have received: investigational therapy, chemotherapy, immunotherapy, radiotherapy, or systemic graft versus host disease (GVHD) therapy
Exception: steroids, hydroxyurea and/or leukapheresis are allowed to control blast count prior to the first dose of study drug
Investigational therapy, chemotherapy, immunotherapy, radiotherapy, or systemic graft versus host disease (GVHD) therapy within two weeks or five half-lives (whichever is shorter)
Cannot have received: allo-HCT
Exception: prior allo-HCT less than three months from the time of enrollment
Prior allo-HCT less than three months from the time of enrollment
Lab requirements
Blood counts
No hematologic parameters for inclusion; transfusion-dependent patients are eligible and platelet counts should be maintained > 10,000/mm^3 throughout cycles 1 and 2
Kidney function
Estimated creatinine clearance ≥ 30 ml/min (Cockcroft-Gault) or serum creatinine ≤ 2 x ULN
Liver function
Bilirubin ≤ 1.5 x ULN (unless due to Gilbert's syndrome or B-ALL or non-hepatic origin); AST/ALT ≤ 3 x ULN (unless due to B-ALL)
Bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or B-ALL or non-hepatic origin); AST/ALT ≤ 3 x ULN (unless due to B-ALL); Estimated creatinine clearance ≥ 30 ml/min (Cockcroft-Gault) or serum creatinine ≤ 2 x ULN; No hematologic parameters for inclusion; transfusion-dependent patients are eligible and platelet counts should be maintained > 10,000/mm^3 throughout cycles 1 and 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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