Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT03150693

Purpose

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Official Title

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Eligibility


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 (< 7 days) with corticosteroids or
   hydroxyurea and a single dose of intrathecal cytarabine

   - 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 =< 7 days prior to registration is required

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

   - Patients with down syndrome are excluded from this study

   - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of
   normal (ULN), unless suspected leukemic involvement of the liver

   - Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic
   involvement of the liver

   - Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault

RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)

   - Completion of remission induction therapy

   - Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater
   than 25% lymphoblasts) will not be eligible to be randomized

      - Rating: M0, M1; Blast Cells (%): 0-5.0

      - Rating: M2; Blast Cells (%): 5.1-25.0

      - Rating: M3; Blast Cells (%): > 25-50

      - Rating: M4; Blast Cells (%): > 50.0

      - The term "blast cell" includes any cell that cannot be classified as a more
      mature normal element, and includes "leukemic cells," pathologic lymphocytes, and
      stem cells

   - No ascites, effusions or significant edema

   - Absolute neutrophil count (ANC) >= 1,000/mm^3

   - Platelet count >= 100,000/mm^3

   - Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known
   Gilbert's syndrome

   - Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN)

   - Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V)

   - Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy
   (Course V)

   - Patient is in complete continuous first remission at entry into A041501-HO1

   - Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of
   therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75
   mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX
   dosing based on laboratory or clinical parameters is acceptable)

   - Patient is able and willing to use the Medication Event Monitoring System (MEMS)
   TrackCap (e.g. not using a pillbox)

Intervention(s):

drug: Pegylated L-Asparaginase

drug: Allopurinol

drug: Cytarabine

drug: Daunorubicin Hydrochloride

drug: Vincristine Sulfate

drug: Dexamethasone

drug: Methotrexate

procedure: Bone Marrow Aspiration and Biopsy

drug: Cyclophosphamide

drug: Mercaptopurine

biological: Rituximab

drug: Doxorubicin

drug: Thioguanine

biological: Inotuzumab Ozogamicin

other: Laboratory Biomarker Analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Won Chang
650-736-8113

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