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New combo therapy aims to treat leukemia without harsh chemo

NCT ID NCT07313852

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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