Inotuzumab Ozogamicin for B Acute Lymphoblastic Leukemia

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

Recruiting Phase 3 Interventional Study
B Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 39
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
303 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for

This trial is looking for young adults with newly diagnosed B acute lymphoblastic leukemia. Participants will receive a treatment combining inotuzumab ozogamicin and chemotherapy to see how well it works and what side effects may occur.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 39 years old.
  • I have been diagnosed with CD-22 positive B-cell acute lymphoblastic leukemia.
  • I have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • I have completed remission induction therapy.
  • I have a total bilirubin level at or below 1.5 times the upper limit of normal.
  • I have a calculated creatinine clearance of 50 mL/min or higher.

You may not be able to join if

  • I have the BCR-ABL fusion transcript.
  • I have had more than 7 days of prior therapy for acute lymphoblastic leukemia.
  • I am pregnant or nursing.
  • I have Down syndrome.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 molec…
Trial Locations
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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 cytar…
Contacts

Daniel J. DeAngelo, MD, PhD

617-632-2645

daniel_deangelo@dfci.harvard.edu

CONTACT