New combo therapy aims to deepen remissions in tough leukemia
NCT ID NCT05453500
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 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: * 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.
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.
- Can a Chemo-Antibody combo beat a tough leukemia?
- New combo aims to wipe out hidden leukemia cells
- New combo therapy aims to beat leukemia without harsh chemo
- New Antibody-Drug combo aims to tackle tough leukemia
- New combo therapy aims to wipe out leukemia in adults who Can't take standard treatment
- New enzyme combo aims to boost leukemia treatment in High-Risk adults