Acute leukemia incidence and patient survival among children and adults in the United States, 2001-2007.
Graça M Dores, Susan S Devesa, Rochelle E Curtis...
https://pubmed.ncbi.nlm.nih.gov/22086414Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05289687
A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease in T Cell Acute Lymphoblastic Leukemia
Led by Eastern Cooperative Oncology Group · Updated on 2026-05-05
20
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating daratumumab-hyaluronidase as a treatment for patients with T-cell acute lymphoblastic leukemia (T-ALL) who have persistent or recurrent minimal residual disease (MRD) after chemotherapy. The study aims to see if this drug can eliminate MRD that is resistant to chemotherapy and improve survival outcomes, including relapse-free and overall survival. It also evaluates the drug's safety and tolerability, especially in patients who have undergone allogeneic stem cell transplant. Participants receive daratumumab-hyaluronidase injections once weekly for four weeks as an initial course. On Day 29, patients who are MRD negative continue with additional doses every two weeks for eight doses. Those who remain MRD positive receive further weekly doses along with selected chemotherapy drugs over several weeks. The study includes monitoring with flow cytometry to assess MRD status at multiple time points. During the trial, participants undergo blood tests and evaluations to measure MRD response and remission status on Days 29 and 64. Researchers track relapse events and survival outcomes while monitoring for side effects and drug tolerability. The study requires participants to have adequate organ function and performance status and involves regular assessments to ensure safety and treatment effectiveness over the course of the treatment and follow-up periods.
CONDITIONS
Brief Title
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Documented T-cell acute lymphoblastic leukemia (T-ALL) in first or later complete remission (CR) or complete remission with incomplete recovery (CRi) after at least 2 intensive chemotherapy blocks
- Persistent or recurrent minimal residual disease (MRD) at or above 10-4 by flow cytometry
- Central confirmation of MRD status showing persistent or recurrent MRD 10-4
- May have had prior allogeneic stem cell transplant without graft-versus-host disease (GVHD) requiring ongoing immunosuppressive therapy; prednisone = 10 mg/day allowed
- 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, no sperm or egg donation during this period
- Ability and willingness to sign informed consent, including patients with impaired decision-making capacity with legal representative
- Adequate organ and marrow function within 7 days before registration, including ANC 750/bcL, platelets 75,000/bcL, bilirubin 2 mg/dL, AST/ALT 3x upper limit normal, creatinine 1.5x upper limit normal or creatinine clearance 30 ml/min
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B infection must have undetectable viral load on suppressive therapy
- Patients cured or under treatment with undetectable viral load for hepatitis C
- Patients with prior CNS involvement allowed if no active CNS disease at registration
- Patients with other cancers allowed if they do not interfere with study safety or efficacy
- Cardiac function assessed as New York Heart Association class 2B or better
You will not qualify if you...
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 8 weeks
Participants receive daratumumab-hyaluronidase injections once weekly for 4 weeks. Based on response at Day 29, participants either continue daratumumab-hyaluronidase weekly for 4 additional doses or receive daratumumab-hyaluronidase combined with chemotherapy for 4 weeks.
Weekly visits for up to 8 weeks
Follow-up
Duration - Up to 14 weeks
Participants who achieve MRD negative response after initial treatment receive daratumumab-hyaluronidase every two weeks for 8 doses as ongoing treatment and monitoring.
Biweekly visits for up to 14 weeks
Trial Site Locations
Total: 1 location
1
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
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Research Team
S
Shira Dinner, MD
T
Talha Badar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Stephen P Hunger, Xiaomin Lu, Meenakshi Devidas...
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P G Steinherz, P S Gaynon, J C Breneman...
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David I Marks, Elisabeth M Paietta, Anthony V Moorman...
https://pubmed.ncbi.nlm.nih.gov/19828704Late MRD response determines relapse risk overall and in subsets of childhood T-cell ALL: results of the AIEOP-BFM-ALL 2000 study.
Martin Schrappe, Maria Grazia Valsecchi, Claus R Bartram...
https://pubmed.ncbi.nlm.nih.gov/21719599Oncogenetics and minimal residual disease are independent outcome predictors in adult patients with acute lymphoblastic leukemia.
Kheira Beldjord, Sylvie Chevret, Vahid Asnafi...
https://pubmed.ncbi.nlm.nih.gov/24740809Clinical significance of minimal residual disease quantification in adult patients with standard-risk acute lymphoblastic leukemia.
Monika Brüggemann, Thorsten Raff, Thomas Flohr...
https://pubmed.ncbi.nlm.nih.gov/16195338Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies.
Nicola Gökbuget, Michael Kneba, Thorsten Raff...
https://pubmed.ncbi.nlm.nih.gov/22442346Predicting relapse risk in childhood acute lymphoblastic leukaemia.
David T Teachey, Stephen P Hunger
https://pubmed.ncbi.nlm.nih.gov/23808872T-cell acute lymphoblastic leukemia in patients 1-45 years treated with the pediatric NOPHO ALL2008 protocol.
P Quist-Paulsen, N Toft, M Heyman...
https://pubmed.ncbi.nlm.nih.gov/31611626