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

Conditions

• B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Allopurinol — DRUG
  Given PO
• Cytarabine — DRUG
  Given IT, IV, SC
• Daunorubicin Hydrochloride — DRUG
  Given IV
• Vincristine Sulfate — DRUG
  Given IV
• Dexamethasone — DRUG
  Given PO or IV
• Pegylated L-Asparaginase — DRUG
  Given IV
• Methotrexate — DRUG
  Given IT, IV, PO
• Bone Marrow Aspiration and Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Cyclophosphamide — DRUG
  Given IV
• Mercaptopurine — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Doxorubicin — DRUG
  Given IV
• Thioguanine — DRUG
  Given PO
• Inotuzumab Ozogamicin — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

Start date

Sep 20, 2017

Status verified

Jun 2026

Primary completion

Mar 1, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

310 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (frontline chemotherapy)
  See detailed description.
• Experimental: Arm II (frontline chemotherapy, inotuzumab ozogamicin)
  Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.

Primary Outcome Measure

EFS [ Time Frame: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years ]

Central Contacts

• Daniel J. DeAngelo, MD, PhD
  617-632-2645
  [email protected]

Locations (455)

Find similar trials in Birmingham, AL

Related Studies

• Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
  PHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
  PHASE3 · Recruiting · Children's Oncology Group · Birmingham, Alabama
• Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
  PHASE2 · Recruiting · John Lister · Pittsburgh, Pennsylvania
• A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama