Using inotuzumab ozogamicin with chemotherapy to treat acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of inotuzumab ozogamicin combined with low-intensity chemotherapy in treating patients with acute lymphoblastic leukemia (ALL). The study aims to determine the maximum tolerated dose of inotuzumab ozogamicin in elderly patients and evaluate its efficacy in those who are unfit for intensive therapy. The trial includes a dose-escalation phase followed by an efficacy evaluation phase, focusing on both treatment response and side effects. Additionally, it explores genomic alterations that may predict treatment outcomes and compares different methods for assessing minimal residual disease.

Why it matters

Who can join: the full rules

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 unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.

   These patients are defined as having at least one of the below comorbidities:
   1. ECOG performance status ≥ 2
   2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
   3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)
   4. Creatinine clearance \< 45 mL/min, and
   5. Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal

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   1. If they achieved CR, they are assessable only for event-free and overall survival, or
   2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival
3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible.
4. Zubrod performance status 0-3.
5. Adequate liver function (bilirubin \< 1.95 mg/dL and SGPT or SGOT \< 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL/min/1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \< 2.6 mg/dL and creatinine \< 3 mg/dL.
6. Provision of written informed consent.
7. Patients in first remission are eligible.
8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible.

Exclusion Criteria:

1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.
2. Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination).
3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded.
4. Patients with active hepatitis are excluded.
5. Pregnant or breast-feeding women are excluded.

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Elias Jabbour, MD — M.D. Anderson Cancer Center
• Study coordinator: Elias Jabbour, MD
• Email: ejabbour@mdanderson.org
• Phone: 713-792-7026

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inotuzumab ozogamicin and blinatumomab with optional ponatinib for CD22-positive B-cell acute lymphoblastic leukemia

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• Erwinia asparaginase and venetoclax added to blinatumomab for relapsed/refractory CD19+ B‑ALL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.