Clinical Trial 20733

• Overview

  Study Title:

  A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzomab Ozogamicin (a conjugated anti-CD22 monoclonal antibody) to Frontline Therapy in Young Adults (ages 18-39 years) with Newly Diagnosed Precusor B-cell ALL

  Summary:

  This study is currently being conducted at Moffitt's Memorial Healthcare site in Hollywood, Florida.

  Objective:

  "Confirmation of tolerability: To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403. Phase III: To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant."

• Inclusion Criteria

  REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
  • Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible
  • Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity
  • No prior therapy except for limited treatment (> No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC
  • Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
  • Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented on case report forms
  • Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done => Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients with down syndrome are excluded from this study
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) == 50 mL/min by Cockcroft-Gault
  • Additional criteria apply

• Exclusion Criteria

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