Actively Recruiting
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
Led by Eastern Cooperative Oncology Group · Updated on 2026-05-05
20
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
E
Eastern Cooperative Oncology Group
Lead Sponsor
J
Janssen, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented T-cell Acute Lymphoblastic Leukemia (T-ALL)
- In first or later hematologic complete remission (CR) or complete remission with incomplete recovery (CRi) after at least 2 blocks of intensive chemotherapy
- Persistent or recurrent minimal residual disease (MRD) of 10-4 or greater confirmed by central flow cytometry
- Prior allogeneic stem cell transplant allowed if no ongoing immunosuppressive therapy for graft-versus-host disease; prednisone up to 10 mg/day permitted
- ECOG performance status between 0 and 2
- Negative pregnancy test within 14 days before registration for patients of childbearing potential
- Use of effective contraception or abstinence during the study and for 3 months after last treatment dose; agreement to avoid sperm or egg donation during this time
- Ability to understand and willing to sign informed consent; patients with impaired decision-making capacity may participate with a legally authorized representative
- Adequate organ and marrow function measured within 7 days before registration, including ANC ≥ 750/µL, platelets ≥ 75,000/µL, bilirubin ≤ 2 mg/dL, AST/ALT ≤ 3 times institutional upper limit, creatinine ≤ 1.5 times upper limit or clearance > 30 ml/min
- HIV-positive patients with undetectable viral load on effective therapy within 6 months eligible
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy if needed
- Patients with treated or cured hepatitis C, or undetectable viral load if currently treated, are eligible
- Prior CNS involvement allowed if no active CNS disease at registration
- Previous or concurrent malignancies allowed if not interfering with safety or efficacy assessment
- Cardiac function classified as New York Heart Association Class 2B or better
You will not qualify if you...
- Pregnant or breastfeeding due to potential harm to fetus or nursing infants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Shira Dinner, MD
CONTACT
T
Talha Badar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here