B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT07313852
A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Blinatumomab Injection in people with B-cell Acute Lymphoblastic Leukemia and B-Cell Acute Lymphoblastic Leukemia, Adult, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, B-Cell Acute Lymphoblastic Leukemia, Adult, B-ALL
- What is being tested?
- Blinatumomab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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%
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jae Park, MD, 646-608-3743
About this study
Official title: 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).
- Being tested
- Blinatumomab Injection
- Keywords
- B-cell Acute Lymphoblastic Leukemia, B-Cell Acute Lymphoblastic Leukemia, Adult, B-ALL, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinatumomab InjectionDrug
Blinatumomab given via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Participants With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia | Experimental | Participants will be newly diagnosed with CD19+ and CD22+ B-cell Acute Lymphoblastic Leukemia Receives: Drug: Blinatumomab Injection |
| Phase II: Participants With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia | Experimental | Participants who receive at least one dose of the Inotuzumab will be evaluable for the primary endpoint Receives: Drug: Blinatumomab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose/MTD
To establish the MTD in phase 1 part of the study
Measured: 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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Park, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313852
- Sponsor's protocol ID
- 26-035
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.