Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma (ALLO-T-DART)
September 8, 2026 updated by: New York Medical College
Phase I Trial of Targeted Immunotherapy With Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults With High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.
Daratumumab (DARA) treatment post-HCT:
Phase 1: 3 dose levels to determine safety (15 patients)
Dose expansion cohort (DEC): Further evaluation of PK and PD (correlative studies/exploratory endpoints) to guide future selection of RP2D (15 patients)
Treatment Schedule:
- Induction: DARA IV weekly x 8 doses (Weeks 1-8)
- Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
- Maintenance: DARA IV every 4 weeks (Stop at Day +270)
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Harrison, RN, MSN
- Phone Number: 6172857844
- Email: lauren_harrison@nymc.edu
Study Contact Backup
- Name: Erin Morris, RN
- Phone Number: 7149645359
- Email: erin_morris@nymc.edu
Study Locations
-
-
Arizona
-
Phoeniz, Arizona, United States, 85016
- Not yet recruiting
- Phoenix Children's Hospital
-
-
California
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University Children's Hospital
-
Contact:
- Hisham Abdel-Azim, MD
- Phone Number: (909) 558-4076
- Email: habdelazim@llu.edu
-
Los Angeles, California, United States, 90095
- Not yet recruiting
- University of California
-
Contact:
- Ted Moore, MD
- Phone Number: (310) 825-6708
- Email: TBMoore@mednet.ucla.edu
-
San Francisco, California, United States, 94143
- Recruiting
- University of California
-
Contact:
- Rohini Jain, MD
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Not yet recruiting
- Children's Hospital Colordao
-
Contact:
- Taymour Hammoudi, MD
- Phone Number: (720) 777-8563
- Email: taymour.hammoudi@cuanschutz.edu
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20010
- Not yet recruiting
- Children's National Medical Center
-
Contact:
- Anant Vatsayan, MBBS
- Phone Number: (202) 476-4840
- Email: avatsayan@childrensnational.org
-
-
Florida
-
Gainsville, Florida, United States, 32608
- Recruiting
- University of Florida
-
Contact:
- Jordan Milner, MD
- Phone Number: (352) 273-9120
- Email: jordan.milner@peds.ufl.edu
-
St. Petersburg, Florida, United States, 33701
- Not yet recruiting
- John Hopkins All Children's Hospital
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Children's Hospital
-
Contact:
- April Rahrig, MD
- Phone Number: (260) 227-0353
- Email: alrahrig@iu.edu
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Amy Keating, MD
- Phone Number: (857) 215-2881
- Email: amy_keating@dfci.harvard.edu
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Helen DeVos Children's Hospital
-
Contact:
- Troy Quigg, DO
- Phone Number: (616) 391-3962
- Email: troy.quigg@corewellhealth.org
-
-
New York
-
Vallhala, New York, United States, 10595
- Recruiting
- New York Medical College
-
Contact:
- Mitchell Cairo, MD
- Phone Number: 914-594-3650
- Email: mitchell_cairo@nymc.edu
-
Contact:
- Lauren Harrison, MSN
- Phone Number: 617-285-7844
- Email: lauren_harrison@nymc.edu
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Not yet recruiting
- Nationwide Children's Hosptial
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Alix Seif, MD
- Phone Number: (215) 590-9996
- Email: seifa@chop.edu
-
-
Texas
-
Houston, Texas, United States, 77030
- Not yet recruiting
- MD Anderson Cancer Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Not yet recruiting
- Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 39 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Interventional
Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: Daratumumab (DARA) treatment post-HCT
|
Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor. Daratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients with dose limiting toxicity (per CTCAE v.5)
Time Frame: 60 days
|
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relapse free survival
Time Frame: 1 year
|
To measure relapse free survival in patients post HCT and daratumumab
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mitchell Cairo, MD, New York Medical College
- Study Chair: Troy Quigg, DO, Helen DeVos Children's Hospital
- Study Chair: Allyson Flower, MD, New York Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
July 13, 2021
First Submitted That Met QC Criteria
July 13, 2021
First Posted (Actual)
July 22, 2021
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Hemic and Lymphatic Diseases
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- Antineoplastic Agents
- daratumumab
Other Study ID Numbers
- NYMC-598
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.