Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo therapy aims to deepen remissions in tough leukemia

NCT ID NCT05453500

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding the targeted antibody tafasitamab to a standard chemotherapy regimen (DA-EPOCH, with or without rituximab) can improve outcomes for adults newly diagnosed with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL). The study enrolls 32 adults who are not good candidates for more intensive pediatric-style treatment. The main goal is to see if more patients achieve a deep remission (negative for minimal residual disease) after one cycle of the new combination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tafasitamab (a monoclonal antibody) plus chemotherapy (DA-EPOCH with or without rituximab)
What this could lead to
If successful, this combination could improve the chance of achieving deep remission (MRD-negative) after one cycle of treatment, potentially pointing toward a more effective first-line therapy for this type of leukemia.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 32 participants, so results may not apply broadly. Adding tafasitamab to chemotherapy may increase side effects without improving outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

Mar 2023

Expected to finish

May 2031

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 years and older

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: * Adults (age 18 years and older) with newly-diagnosed CD19+ Ph- B-ALL * In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., \>= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen * Marrow or blood involvement detectable by MFC * Total bilirubin =\< 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =\< 4.0 x ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =\< 5.0 x ULN and ALT/AST are =\< 8.0 x ULN) * Calculated creatinine clearance of \> 30 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible * As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL) * Ability to give informed consent and comply with the protocol * Anticipated survival of at least 3 months, independent of ALL Exclusion Criteria: * Burkitt lymphoma/leukemia * No prior systemic therapy for ALL except to control acute symptoms and/or hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.) * No isolated extramedullary or known parenchymal central nervous system (CNS) disease * Known hypersensitivity or intolerance to any of the agents under investigation * Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol * May not be pregnant or nursing * Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \[1\] surgically sterilized, or \[2\] postmenopausal \[i.e., a woman who is \> 50 years old or who has not had menses for \>=1 year\], or \[3\] not heterosexually active)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for B acute lymphoblastic leukemia, philadelphia chromosome negative are added.

Vår säkerhetsrekommendation!

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.

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.