Targeted immunotherapy for high-risk T-cell leukemia and lymphoma in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I trial evaluates the safety of daratumumab (DARA) administered after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) in children, adolescents, and young adults with high-risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). The study includes pre- and post-HCT assessments of minimal residual disease (MRD) and immune reconstitution to correlate these factors with patient outcomes. Participants will receive DARA in a structured treatment schedule, including induction, consolidation, and maintenance phases. The trial aims to identify the optimal dosing and safety profile of DARA in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 0-39yrs
* T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including secondary malignancy)
* Planned allogeneic stem cell transplantation with donor identified
* Performance status ≥ 60%
* Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Meet organ function requirements
* Signed IRB approved informed consent

Exclusion Criteria:

* May not have had a prior autologous or allogenic stem cell transplant
* May not have uncontrolled, systemic infection at the time of enrollment
* Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
* Must not be pregnant or actively breast feeding
* Seropositive for HIV, hepatitis B or hepatitis C
* COPD
* Asthma
* Clinically significant cardiac disease

Where it's running

• Loma Linda University Children's Hospital
  Loma Linda, California, United States Recruiting
• University of California
  San Francisco, California, United States Recruiting
• University of Florida
  Gainsville, Florida, United States Recruiting
• Riley Children's Hospital
  Indianapolis, Indiana, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Helen DeVos Children's Hospital
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Lauren Harrison, RN, MSN
• Email: lauren_harrison@nymc.edu
• Phone: 6172857844

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.