New drug aimed at wiping out hidden leukemia cells after chemo
NCT ID NCT05289687
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This study tests whether daratumumab can eliminate tiny amounts of leukemia that remain after chemotherapy in people with T-cell acute lymphoblastic leukemia (T-ALL). About 20 adults whose cancer has come back or not fully cleared will receive the drug. The goal is to see if it can achieve complete remission and clear all detectable disease.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Patient must have documented T cell ALL and must be in first or later hematologic CR or CRi after a minimum of 2 blocks of intensive chemotherapy. * Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10-4. * Institution must have received central MRD status test results confirming persistent or recurrent MRD ≥ 10-4 by flow cytometry. * Patient may have undergone a prior allogeneic stem cell transplant, but patient may not have Grafts Versus Host Disease (GVHD) that requires ongoing immunosuppressive therapy. Patient may receive prednisone if the dose is ≤ 10 mg per day. * Patient must have an ECOG performance status 0-2. * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 registration to rule out pregnancy. * Patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue to 3 months after the last dose of protocol treatment. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or donating eggs while on study treatment and for 3 months after the last dose of protocol treatment. * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 7 days prior to Step 1 registration). * Absolute neutrophil count (ANC) ≥ 750/μL * Platelets ≥ 75,000/μL * Total or Direct bilirubin ≤ 2 mg/dL * AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN * Creatinine ≤ 1.5 x institutional ULN or Creatinine Clearance \> 30 ml/min * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with prior CNS involvement are eligible as long as they do not have active CNS involvement at time of Step 1 registration. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Exclusion Criteria: -Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Northwestern
RECRUITINGChicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pill after transplant: new hope to stop t-cell cancer relapse
- Personalized chemo dosing may boost survival in kids with High-Risk leukemia
- Engineered immune cells take aim at Hard-to-Treat T-Cell cancers
- Engineered immune cells take aim at stubborn blood cancers
- Double-Barreled immune attack aims to wipe out T-ALL
- Chemotherapy showdown: which combo works best for T-Cell cancers in kids?