Inotuzumab Ozogamicin with Chemotherapy for Acute Lymphoblastic Leukemia

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Recruiting Phase 1 Phase 2 Interventional Study
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Burkitt-Like Lymphoma With 11q Aberration High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements High Grade B-Cell Lymphoma, Not Otherwise Specified Recurrent B Acute Lymphoblastic Leukemia Recurrent Burkitt Lymphoma Refractory B Acute Lymphoblastic Leukemia Refractory Burkitt Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
276 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for

This trial is looking for patients with acute lymphoblastic leukemia (ALL) to test a new treatment combining inotuzumab ozogamicin and chemotherapy. Participants will help researchers understand the safety and effectiveness of this treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 60 years or older with recently diagnosed ALL
  • I am between 18 and 60 years old and have untreated ALL with certain health conditions
  • I have a performance status of 0-3
  • I have provided written consent to participate
  • I have adequate liver and kidney function
  • I am in my first remission or have refractory-relapsed ALL or certain types of lymphoma

You may not be able to join if

  • I have newly diagnosed Burkitt's leukemia or lymphoma
  • I have active heart disease
  • My heart's ejection fraction is less than 40%
  • I have active hepatitis
  • I am pregnant or breastfeeding

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 I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed. 2. Patients unf…
Contacts

Elias Jabbour, MD

713-792-7026

ejabbour@mdanderson.org

CONTACT