New combo therapy aims to treat leukemia without harsh chemo
NCT ID NCT07313852
First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This study tests whether combining two drugs, inotuzumab and blinatumomab, is safe and effective for adults newly diagnosed with B-cell acute lymphoblastic leukemia (B-ALL). The trial includes 26 people aged 18 and older who are either 55+ or cannot tolerate standard chemotherapy. Both drugs target specific proteins on leukemia cells, and the goal is to achieve remission without the severe side effects of traditional chemo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inotuzumab and blinatumomab
- What this could lead to
- If this works, it could offer a less toxic treatment option for older or frail adults with B-ALL who cannot handle standard chemotherapy.
- What could go wrong
- This is an early-phase trial with only 26 participants, so results may not apply widely. The combination could cause serious side effects like infections or organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-ALL are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Antibody-Guided chemotherapy aims to give relapsed leukemia patients a second shot
- Can a Pre-Transplant drug keep leukemia from returning?
- Fighting fat to fight leukemia: could a diet and exercise plan boost chemo?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can donor immune cells be engineered to fight blood cancer?
- Can a Chemo-Antibody combo beat a tough leukemia?