What is this study trying to find out about acute lymphoblastic leukemia?

This study is evaluating how well the drugs inotuzumab ozogamicin and blinatumomab, with or without ponatinib, work in adults with a specific type of leukemia called CD22-positive B-cell acute lymphoblastic leukemia. It aims to understand treatment tolerability, response rates, and survival outcomes. The research is sponsored by the National Cancer Institute (NCI) to help improve care for leukemia patients.

Who may be eligible for this acute lymphoblastic leukemia clinical trial?

Adults aged 18 years and older with newly diagnosed, recurrent, or refractory CD22-positive B-cell acute lymphoblastic leukemia may be eligible. Both males and females can participate. Important factors include no active central nervous system leukemia, no prior treatment with certain leukemia drugs, and not being pregnant or nursing. Please review eligibility criteria for more details.

Is there any cost to participate in this acute lymphoblastic leukemia clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participating may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID03739814

Evaluating Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib for Adults With Newly Diagnosed or Recurrent CD22-Positive B-Cell Acute Lymphoblastic Leukemia

Led by National Cancer Institute (NCI) · Updated on 2026-08-04

Participants Needed

277

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate how well inotuzumab ozogamicin and blinatumomab, with or without ponatinib, work in treating adults with newly diagnosed, recurrent, or refractory CD22-positive B-lineage acute lymphoblastic leukemia ALL. The study focuses on patients with Philadelphia chromosome-negative or positive B-cell ALL, including those who are older or transplant-ineligible. It also seeks to assess safety, tolerability, survival outcomes, response rates, and molecular markers related to treatment effectiveness. Participants are assigned to one of three cohorts based on their disease status and Philadelphia chromosome presence. Cohorts 1 and 2 receive inotuzumab ozogamicin intravenously on specific days, followed by blinatumomab infusions, while cohort 3 receives a combination of ponatinib orally, inotuzumab ozogamicin, blinatumomab, dexamethasone, methotrexate, and other treatments over multiple courses. Treatment courses vary in length from 21 to 126 days, with maintenance ponatinib for 24 months in cohort 3. Bone marrow aspirations, biopsies, lumbar punctures, and sample collections are performed throughout the study. During the study, participants undergo regular assessments including blood and cerebrospinal fluid sample collections, bone marrow evaluations, and monitoring for treatment response and safety. Researchers measure event-free survival, overall survival, relapse-free survival, response rates, minimal residual disease negativity, and molecular response over periods up to 10 years. After treatment completion, participants are followed every 3 months for 3 years, then every 6 months up to 10 years to monitor long-term outcomes.

CONDITIONS

Brief Title

Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) with CD22 expression on at least 20% of lymphoblasts
Philadelphia chromosome/BCR-ABL1 status known (positive or negative)
No active central nervous system leukemia; only CNS-1 disease allowed
No pregnancy or nursing; negative pregnancy test for women of childbearing potential
ECOG performance status 0 to 2
No unstable or impaired cardiac disease
For patients with HIV, on effective therapy with undetectable viral load
For patients with hepatitis B or C, meeting specific treatment and liver health criteria
No clinically relevant neurologic disorders
No recent additional malignancies except certain treated cancers or remission for at least 2 years
No significant ventricular arrhythmia or chronic bradycardia unless pacemaker implanted
No chronic liver disease or history of sinusoidal obstruction syndrome
No uncontrolled infections or recent deep tissue infections
Laboratory values within specified limits for bilirubin, liver enzymes, creatinine, and QT interval
Cohort 1: Age 60 or older, newly diagnosed Ph-negative B-cell ALL, no prior ALL treatment except limited therapy
Cohort 1: No planned stem cell transplantation
Cohort 2: Age 18 or older, relapsed or refractory Ph-negative B-cell ALL in salvage 1 or 2, no isolated extramedullary relapse
Cohort 2: Prior allogeneic stem cell transplant completed at least 4 months prior, no graft-versus-host disease, and immunosuppressive therapy completed at least 30 days prior
Cohort 2: No previous treatment with inotuzumab ozogamicin, blinatumomab, or other CD22/CD19-directed therapies
Cohort 3: Age 75 or older or age 18 or older and ineligible for certain chemotherapy regimens
Cohort 3: Philadelphia chromosome/BCR-ABL1-positive B-cell ALL
Cohort 3: No prior ALL treatment except limited therapy including BCR-ABL1-targeted inhibitors
Cohort 3: No chronic, strong CYP3A4 inducers

You will not qualify if you...

Active central nervous system leukemia or symptomatic neurological dysfunction within 28 days prior to registration
Pregnancy or nursing
Unstable or uncontrolled cardiac disease within 6 months prior to registration
Impaired cardiac function (LVEF less than 45% or advanced congestive heart failure)
Clinically relevant neurologic disorders such as epilepsy, stroke, severe brain injury, or dementia
Prior additional malignancy except certain treated cancers or remission less than 2 years
Significant ventricular arrhythmias or unexplained syncope without pacemaker
Chronic liver disease including cirrhosis
History of sinusoidal obstruction syndrome or veno-occlusive disease of the liver
Uncontrolled infection or recent deep tissue infection within 4 months prior
Laboratory values exceeding specified limits for bilirubin, liver enzymes, creatinine, or QT interval
Prior treatment with inotuzumab ozogamicin, blinatumomab, or other CD22/CD19-directed therapies for cohort 2
Use of chronic strong CYP3A4 inducers for cohort 3

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Evaluating Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib for Adults With Newly Diagnosed or Recurrent CD22-Positive B-Cell Acute Lymphoblastic Leukemia

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria