A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia

April 15, 2026 updated by: Memorial Sloan Kettering Cancer Center

A Phase 1/2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia

The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All protocol activities)
        • Contact:
          • Jae Park, MD
          • Phone Number: 646-608-3743

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years of age.

  • Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics

    • Patients ≥55 years old, OR
    • Patients 18-54 years old who decline or are deemed unfit for conventional chemotherapy with at least one of the following criteria:
  • ECOG performance status of 2 or more
  • Severe cardiac comorbidity (including congestive heart failure requiring treatment)
  • Known pulmonary comorbidity (including DLCO ≤65% or FEV1 ≤65%)
  • Renal comorbidity (including creatinine clearance 30-45 mL/min)
  • Relapsed or refractory CD19+ and CD22+ B-ALL
  • Patients with extramedullary disease will be allowed as long as they have detectable disease by flow cytometry in the bone marrow
  • Peripheral absolute lymphoblast count of ≤ 10,000/ml after pre-phase (not required for enrollment but required to proceed with first dose of inotuzumab).
  • Philadelphia chromosome negative by FISH/karyotype for t(19;22) or RT PCR for bcr-abl transcript.
  • CD19 and CD22 expression will be confirmed by enrolling institutions prior to study registration by flow cytometry and/or IHC.
  • Creatinine clearance ≥30 mL/min
  • Total bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤3.0x upper limit of normal (ULN)
  • QTcF ≤ 480
  • Ejection fraction ≥ 50%

Exclusion Criteria:

  • Patients with Burkitt's lymphoma, T-ALL, CML in lymphoid blast crisis and mixed phenotype acute leukemia (MPAL).
  • Patients with newly diagnosed B-ALL who received prior treatments, with the exception of corticosteroid, hydroxyurea, or one dose of vincristine, are ineligible.
  • Patients with Ph+ B-ALL by FISH or RT PCR.
  • ECOG performance status >3.
  • Left ventricular ejection fraction (LVEF) <50%.
  • History of sinusoidal obstruction syndrome (SOS), also known as veno-occlusive disease (VOD).
  • Prior treatment with inotuzumab
  • History of liver cirrhosis
  • Ongoing need for systemic T-cell suppressive therapy (e.g. corticosteroids, tacrolimus, cyclosporine, etc.) Patients need to be off calcineurin inhibitors for at least 4 weeks in order to be eligible for enrollment.
  • Active Grade 2-4 acute graft versus host disease (GVHD), graded with the modified Glucksberg criteria and/or GVHD requiring systemic steroids in excess of physiologic replacement
  • Moderate or severe chronic GVHD graded with the NIH 2014 criteria
  • Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for the following time periods: female patients of reproductive potential should use effective contraception during treatment and for 8 months after last treatment dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 5 months after the last dose.
  • Patients with HIV or active hepatitis B or hepatitis C infection are ineligible. Patients with a prior history of hepatitis B or hepatitis C who have negative HBV/HCV PCR respectively at the time of screening are eligible
  • Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, or severe brain injuries.
  • Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I: Participants With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Participants will be newly diagnosed with CD19+ and CD22+ B-cell Acute Lymphoblastic Leukemia
Drug: Blinatumomab Injection
Blinatumomab given via subcutaneous injection
Experimental: Phase II: Participants With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
Participants who receive at least one dose of the Inotuzumab will be evaluable for the primary endpoint
Drug: Blinatumomab Injection
Blinatumomab given via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I: Maximum Tolerated Dose/MTD
Time Frame: up to 1 year
To establish the MTD in phase 1 part of the study
up to 1 year
Phase II: Rate of MRD negative CR/CRi (10-4 threshold) at the end of induction.
Time Frame: up to 1 year
To evaluate the efficacy of concurrent inotuzumab at the RP2D and subcutaneous blinatumomab in participants as assessed by rate of MRD negative CR/CRi (10-4 threshold) at the end of induction.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Pfizer
Amgen

Investigators

  • Principal Investigator: Jae Park, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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