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Study of Inotuzumab and Blinatumomab for B-cell Acute Lymphoblastic Leukemia

This study is looking at whether combining two drugs, inotuzumab and blinatumomab, is a safe and effective treatment for people with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL). This type of leukemia affects certain white blood cells. You may be able to join if you are between 18 and 55 years old and have newly diagnosed CD19+ and CD22+ B-ALL. This includes people 55 and older, or those 18-54 who cannot receive standard chemotherapy due to health reasons or an ECOG performance status of 2 or more. The study will measure success by looking at the highest safe dose of the drugs and how many people have very low levels of leukemia cells after treatment. The current recruitment status is unclear.

Study design
This study plans to enroll 26 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for up to 1 year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07313852

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

Not Yet Recruiting
PHASE1Ages 18–55InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~26 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Blinatumomab Injection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Maximum Tolerated Dose/MTD
Measured over up to 1 year
+1 more outcome measured

Conditions

B-cell Acute Lymphoblastic Leukemia
B-Cell Acute Lymphoblastic Leukemia, Adult
B-ALL

Explore related trials

B Acute Lymphoblastic LeukemiaCD19 GeneCD22 Gene

NCT07313852

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jae Park, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Jae Park, MD
[email protected]
646-608-3743
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Phase I: Maximum Tolerated Dose/MTDup to 1 year

    To establish the MTD in phase 1 part of the study

  • Phase II: Rate of MRD negative CR/CRi (10-4 threshold) at the end of induction.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.