A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia
A Phase 1/2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia
1 other identifier
interventional
26
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2025
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
Study Completion
Last participant's last visit for all outcomes
January 1, 2029
April 20, 2026
April 1, 2026
2.6 years
December 30, 2025
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I: Maximum Tolerated Dose/MTD
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.
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
Study Arms (2)
Phase I: Participants With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
EXPERIMENTALParticipants will be newly diagnosed with CD19+ and CD22+ B-cell Acute Lymphoblastic Leukemia
Phase II: Participants With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
EXPERIMENTALParticipants who receive at least one dose of the Inotuzumab will be evaluable for the primary endpoint
Interventions
Blinatumomab given via subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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)
- +2 more criteria
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Amgencollaborator
- Pfizercollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Park, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2025
First Posted
January 2, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.