T-cell Acute Lymphoblastic LeukemiaPhase 1ALLO-T-DARTNCT04972942
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
A Phase 1 study testing Daratumumab in people with T-cell Acute Lymphoblastic Leukemia and T-Cell Acute Lymphoblastic Lymphoma, run by New York Medical College at 16 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 39 years
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 16 sitesUnited States
- Study dates
- 22 May 2023to Sep 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Not yet recruiting
Children's Hospital Colordao
Aurora, Colorado, 80045
Taymour Hammoudi, MD, (720) 777-8563, taymour.hammoudi@cuanschutz.edu
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Amy Keating, MD, (857) 215-2881, amy_keating@dfci.harvard.edu
- Not yet recruiting
Nationwide Children's Hosptial
Columbus, Ohio, 43205
- Recruiting
University of Florida
Gainsville, Florida, 32608
Jordan Milner, MD, (352) 273-9120, jordan.milner@peds.ufl.edu
- Recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Troy Quigg, DO, (616) 391-3962, troy.quigg@corewellhealth.org
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
April Rahrig, MD, (260) 227-0353, alrahrig@iu.edu
- Recruiting
Loma Linda University Children's Hospital
Loma Linda, California, 92354
Hisham Abdel-Azim, MD, (909) 558-4076, habdelazim@llu.edu
- Not yet recruiting
University of California
Los Angeles, California, 90095
Ted Moore, MD, (310) 825-6708, TBMoore@mednet.ucla.edu
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Alix Seif, MD, (215) 590-9996, seifa@chop.edu
- Not yet recruiting
Phoenix Children's Hospital
Phoeniz, Arizona, 85016
- Recruiting
University of California
San Francisco, California, 94143
Rohini Jain, MD, 877-827-3222, cancertrials@ucsf.edu
- Not yet recruiting
John Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
- Recruiting
New York Medical College
Vallhala, New York, 10595
Mitchell Cairo, MD, 914-594-3650, mitchell_cairo@nymc.edu
Lauren Harrison, MSN, 617-285-7844, lauren_harrison@nymc.edu
- Not yet recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Anant Vatsayan, MBBS, (202) 476-4840, avatsayan@childrensnational.org
About this study
Official title: 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.
Read the 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)
- Being tested
- Daratumumab
- Keywords
- immunotherapy, children, adolescents, young adults
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called Darzalex®
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:
- Induction: DARA IV weekly x 8 doses (Weeks 1-8)
- Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24)
- Maintenance: DARA every 4 weeks (Stop at Day +270)
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | Phase 1: 3 dose levels to determine safety (15 patients)
Dose expansion:
Daratumumab (DARA) treatment post-HCT
1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA IV every 4 weeks (Stop at Day +270) Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with dose limiting toxicity (per CTCAE v.5)
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab
Measured: 60 days
Secondary outcomes (1)
Relapse free survival
To measure relapse free survival in patients post HCT and daratumumab
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start22 May 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase 1: 3 dose levels to determine safety. Followed by dose expansion cohort.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Cairo, MD, Study chair, New York Medical CollegeTroy Quigg, DO, Study chair, Helen DeVos Children's HospitalAllyson Flower, MD, Study chair, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972942
- Sponsor's protocol ID
- NYMC-598
- Acronym
- ALLO-T-DART
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No