Actively Recruiting
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
Led by New York Medical College · Updated on 2026-04-15
30
Participants Needed
16
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.
CONDITIONS
Official Title
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 39 years
- Diagnosis of T-cell acute lymphoblastic leukemia in second or later remission with 5% or fewer blasts or relapsed T-cell lymphoblastic lymphoma with complete response after re-induction therapy
- Planned allogeneic stem cell transplantation with donor identified
- Performance status of 60% or higher
- Fully recovered from acute toxic effects of prior chemotherapy, immunotherapy, or radiotherapy
- Meet required organ function criteria
- Signed informed consent approved by IRB
You will not qualify if you...
- Prior autologous or allogeneic stem cell transplant
- Uncontrolled systemic infection at enrollment
- Known allergy, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies, human proteins, or their components
- Pregnant or actively breastfeeding
- Positive for HIV, hepatitis B, or hepatitis C
- Chronic obstructive pulmonary disease (COPD)
- Asthma
- Clinically significant heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Phoenix Children's Hospital
Phoeniz, Arizona, United States, 85016
Not Yet Recruiting
2
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
Actively Recruiting
3
University of California
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
University of California
San Francisco, California, United States, 94143
Actively Recruiting
5
Children's Hospital Colordao
Aurora, Colorado, United States, 80045
Not Yet Recruiting
6
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
7
University of Florida
Gainsville, Florida, United States, 32608
Actively Recruiting
8
John Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Not Yet Recruiting
9
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
New York Medical College
Vallhala, New York, United States, 10595
Actively Recruiting
13
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Not Yet Recruiting
14
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
16
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
L
Lauren Harrison, RN, MSN
CONTACT
E
Erin Morris, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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