RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 39 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years, 2 years, 10 years
  • Procedures mentioned: Biopsies, Infusions, Blood draws, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All patients then undergo bone marrow aspirate and biopsy on day 29."
  • "Patients who are MRD+ and CD19+ after completion of this course receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break."
  • "Patients then undergo bone marrow aspirate and biopsy on day 56."
  • "Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV."
  • "Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity."
  • "Patients undergo multigated acquisition scan (MUGA) or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the side effects of inotuzumab ozogamicin and how well it works with first-line chemotherapy. This drug targets a marker called CD22 on cancer cells and delivers medicine to kill them. The study is for adults ages 18–39 with newly diagnosed B-cell acute lymphoblastic leukemia (ALL), a blood cancer.

This 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. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \[intervention\], work in different ways to stop the growth of cancer 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–39, with newly diagnosed B-cell ALL. More than 20% of leukemia cells must have the CD22 marker.
  • Able to care for yourself and be out of bed for at least half of your waking hours.
  • At entry, liver tests called AST, ALT, and direct bilirubin must be no more than 3 times the normal upper limit, unless leukemia may affect the liver.
  • Kidney filtering rate must be at least 50 mL/min.
  • One dose of cytarabine into the fluid around the spine is allowed before starting treatment. Chemotherapy for the whole body must start within 72 hours of that dose.
  • For step 2, you must finish the first phase of treatment and have no more than 25% immature cells, called blasts, in your bone marrow.
  • For step 2, infection-fighting cells must be at least 750/mm³, and platelets, which help blood clot, must be at least 75,000/mm³.
  • For step 2, AST must be no more than 8 times the normal upper limit. Total bilirubin must be no more than 1.5 times that limit, except with known Gilbert’s syndrome.

Who can't join

  • Burkitt-type ALL.
  • Leukemia with the BCR-ABL gene change or the related chromosome change called t(9;22).
  • Prior ALL treatment, except up to 7 days of steroids or hydroxyurea and one dose of cytarabine into spinal fluid. Long-term steroids for other health problems are allowed.
  • Other prior treatment for acute leukemia, except allowed emergency treatment with steroids or hydroxyurea.
  • Pregnant or breastfeeding. Anyone who can become pregnant must have a negative pregnancy test within 8 days before joining.
  • Down syndrome, because of the risk of too much harm from treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):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 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) \>= 750/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count \>= 75,000/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN) EXCLUSION CRITERIA * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): 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: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): 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 * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 8 days prior to registration is required * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist

Study sites (455)

AK

AL

AR

AZ

CA

CO

CT

FL

GA

HI

IA

ID

IL

KS

KY

  • University of Kentucky/Markey Cancer Center · Lexington, KY 40536Site Public Contact · Study contact · 859-257-3379Ayman Qasrawi · Principal investigatorMore trials in Lexington

LA

MA

MD

  • University of Maryland/Greenebaum Cancer Center · Baltimore, MD 21201Site Public Contact · Study contact · 800-888-8823Shella Saint Fleur-Lominy · Principal investigatorMore trials in Baltimore

MI

MN

MO

MT

NC

ND

NE

NM

NV

NY

OH

OK

OR

PA

RI

SC

TX

UT

VA

WA

WI

WY