Recruiting

Phase 2

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

Sponsor:

Eastern Cooperative Oncology Group

Code:

NCT05289687

Conditions

T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daratumumab / Hyaluronidase Injection

Study Details

Brief summary:

In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.

Conditions

T-cell Acute Lymphoblastic Leukemia

Study ID

NCT05289687

Start date

May 25, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Course 1

Daratumumab-hyaluronidase

Interventions

Daratumumab / Hyaluronidase Injection

Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22

Daratumumab / Hyaluronidase Injection

Patients that are MRD Negative on Day 29 will receive daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57.

Daratumumab / Hyaluronidase Injection

Patients that remain MRD positive on Day 29 will receive a combination of daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57 and chemotherapy selected from the combinations listed below:

Cytarabine 3000 mg/m2, IV, Every 12 hours for 4 doses on Days 37 and 38
Methotrexate 1000 mg/m2, IV, Over 24 hours on Day 36

Methotrexate, Starting dose 100 mg/m2, IV, Days 36, 46, 56
Vincristine, 1.5 mg/m2 (2 mg cap), IV, Days 36, 46, 56
Pegaspargase, 2000 IU/m2 (Capped at 3750 IU), IV Days 37, 57
Methotrexate 15 mg, IT, Days 36, 56

Daratumumab / Hyaluronidase Injection

All patients with MRD negative response after completion of previous course are eligible for daratumumab-hyaluronidase 1800mg/ 30,000 units every 2 weeks on Days 1,15, 29, 43, 57, 71, 85, and 99 for 8 doses.

Primary outcome measure

Complete Remission (CR) [ Time Frame: Day 29 ]
Complete Remission (CR) [ Time Frame: Day 64 ]
Complete Response with Partial Count Recovery (CRh) [ Time Frame: Day 29 ]
Complete Response with Partial Count Recovery (CRh) [ Time Frame: Day 64 ]
Complete Remission incomplete (CRi) [ Time Frame: Day 29 ]
Complete Remission incomplete (CRi) [ Time Frame: Day 64 ]
Minimal Residual Disease Negativity (MRD-) [ Time Frame: Day 29 ]
Minimal Residual Disease Negativity (MRD-) [ Time Frame: Day 64 ]
Morphologic Relapse [ Time Frame: Day 29 ]
MRD Relapse [ Time Frame: Day 29 ]
Morphologic Relapse [ Time Frame: Day 64 ]
MRD Relapse [ Time Frame: Day 64 ]
Refractory [ Time Frame: Day 29 ]
Refractory [ Time Frame: Day 64 ]

Central Contacts and Locations

Central contacts

Shira Dinner, MD

312-695-6180 shira.dinner@nm.org

Talha Badar, MD

904-953-7556 badar.talha@mayo.edu

Locations

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Shira Dinner, MD

312-695-2120 shira.dinner@nm.org

More Information

Sponsor

Eastern Cooperative Oncology Group

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eastern Cooperative Oncology Group on 2026-07-17.