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Daratumumab for T-cell Acute Lymphoblastic Leukemia with Residual Disease

This study is testing a drug called daratumumab-hyaluronidase for adults with T-cell Acute Lymphoblastic Leukemia (T-ALL) who still have minimal residual disease (MRD) after chemotherapy. MRD means a very small number of cancer cells remain. Researchers want to see if daratumumab-hyaluronidase can get rid of these remaining cancer cells. You can join if you are 18 or older, have T-ALL, are in remission (your cancer is not actively growing), but still have MRD. The study aims to see how many patients achieve a complete MRD response by Day 29 and Day 64. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 adult participants.
What's involved
Participants will receive daratumumab-hyaluronidase injections weekly for at least 4 doses. Depending on MRD results, some may receive additional doses or chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at Day 29 and Day 64, indicating follow-up during and shortly after initial treatment phases.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05289687

Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL

Recruiting
PHASE2Ages 18+InterventionalTreatment
Eastern Cooperative Oncology Group
~20 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Daratumumab / Hyaluronidase Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Remission (CR)
Measured over Day 29
+13 more outcomes measured

Conditions

T-cell Acute Lymphoblastic Leukemia

Explore related trials

Pre T-ALL

NCT05289687

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwestern

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Shira Dinner, MD · STUDY_CHAIR · Northwestern University

Who to contact

Shira Dinner, MD
[email protected]
312-695-6180
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Complete Remission (CR)Day 29

    Requires that all of the following be present. * Peripheral Blood Counts * Neutrophil count ≥ 1,000/µL. * Platelet count ≥ 100,000/µL. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Bone Marrow Aspirate and Biopsy * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines. * ≤ 5% T lymphoblasts by flow cytometry. * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.

  • Complete Remission (CR)Day 64

    Requires that all of the following be present. * Peripheral Blood Counts * Neutrophil count ≥ 1,000/µL. * Platelet count ≥ 100,000/µL. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Bone Marrow Aspirate and Biopsy * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines. * ≤ 5% T lymphoblasts by flow cytometry. * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.

  • Complete Response with Partial Count Recovery (CRh)Day 29

    The same as for CR except with unsupported platelets \> 50,000/μL, hemoglobin \> 7 g/dL, and absolute neutrophil count \> 500/μL.

  • Complete Response with Partial Count Recovery (CRh)Day 64

    The same as for CR except with unsupported platelets \> 50,000/μL, hemoglobin \> 7 g/dL, and absolute neutrophil count \> 500/μL.

  • Complete Remission incomplete (CRi)Day 29

    All the same response criteria in peripheral blood and bone marrow as CR with the exception that there is incomplete platelet recovery (platelets \> 75,000/uL but \< 100,000/μL independent of platelet transfusions) or incomplete neutrophil count recovery \> 750/uL but \< 1000/μL.

  • Complete Remission incomplete (CRi)Day 64

    All the same response criteria in peripheral blood and bone marrow as CR with the exception that there is incomplete platelet recovery (platelets \> 75,000/uL but \< 100,000/μL independent of platelet transfusions) or incomplete neutrophil count recovery \> 750/uL but \< 1000/μL.

  • Minimal Residual Disease Negativity (MRD-)Day 29

    Bone marrow lymphoblast percent \< 0.01% (\< 10-4) by flow cytometry in a patient that fulfills count requirements for CR/CRh/CRi..

  • Minimal Residual Disease Negativity (MRD-)Day 64

    Bone marrow lymphoblast percent \< 0.01% (\< 10-4) by flow cytometry in a patient that fulfills count requirements for CR/CRh/CRi..

  • Morphologic RelapseDay 29

    Bone Marrow Aspirate and Biopsy * Presence of \> 5% T lympho-blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.

  • MRD RelapseDay 29

    • Relapse following MRD negativity is defined as bone marrow T lymphoblast percent ≥ 0.01% (10-4).

  • Morphologic RelapseDay 64

    Bone Marrow Aspirate and Biopsy * Presence of \> 5% T lympho-blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.

  • MRD RelapseDay 64

    • Relapse following MRD negativity is defined as bone marrow T lymphoblast percent ≥ 0.01% (10-4).

  • RefractoryDay 29

    Failure to achieve MRD negativity as defined by bone marrow with CR/CRh/CRi with T lymphoblast percent ≥ 0.01% (10-4).

  • RefractoryDay 64

    Failure to achieve MRD negativity as defined by bone marrow with CR/CRh/CRi with T lymphoblast percent ≥ 0.01% (10-4).