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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
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
California - Northern
Alliance for Clinical Trials in Oncology
 
Acronym NCT No.
NCT03150693
 
Study Type Phase
INTERVENTIONAL
Phase III
 
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.
 
Detailed Description
 
 
 
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 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)
 
Exclusion Criteria
  • 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 with M2 marrow or better are eligible
  • patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized 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 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 No ascites, effusions or significant edema
 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
  • Hematologic Diseases
  • Abortifacient Agents
  • Hormones
  • Abortifacient Agents, Nonsteroidal
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Alkylating Agents
  • Immune System Diseases
  • Allopurinol
  • Immunoconjugates
  • Antibiotics, Antineoplastic
  • Immunologic Factors
  • Antiemetics
  • Immunoproliferative Disorders
  • Anti-Infective Agents
  • Immunosuppressive Agents
  • Anti-Inflammatory Agents
  • Immunotoxins
  • Antimetabolites
  • Inotuzumab Ozogamicin
  • Antimetabolites, Antineoplastic
  • Leukemia
  • Antimitotic Agents
  • Leukemia, Lymphoid
  • Antineoplastic Agents
  • Lymphatic Diseases
  • Antineoplastic Agents, Alkylating
  • Lymphoproliferative Disorders
  • Antineoplastic Agents, Hormonal
  • Mercaptopurine
  • Antineoplastic Agents, Immunological
  • Methotrexate
  • Antineoplastic Agents, Phytogenic Tubulin Modulators
  • Mitosis Modulators
  • Antioxidants
  • Molecular Mechanisms of Pharmacological Action
  • Antirheumatic Agents
  • Myeloablative Agonists
  • Antiviral Agents
  • Neoplasms
  • Asparaginase
  • Nucleic Acid Synthesis Inhibitors
  • Autonomic Agents
  • Pegaspargase
  • Cyclophosphamide
  • Peripheral Nervous System Agents
  • Cytarabine
  • Physiological Effects of Drugs
  • Daunorubicin
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Dermatologic Agents
  • Protective Agents
  • Dexamethasone
  • Reproductive Control Agents
  • Doxorubicin
  • Rituximab
  • Enzyme Inhibitors
  • Thioguanine
  • Folic Acid Antagonists
  • Topoisomerase II Inhibitors
  • Free Radical Scavengers
  • Topoisomerase Inhibitors
  • Gastrointestinal Agents
  • Vincristine
  • Glucocorticoids
  • Neoplasms by Histologic Type
  • Gout Suppressants
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Deer Valley
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Leandro Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Marie Suga
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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