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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04972942
- Acronym / sponsor ID
- ALLO-T-DART / NYMC-598
- Keywords
- immunotherapy, children, adolescents, young adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: 3 dose levels to determine safety. Followed by dose expansion cohort.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Drug: DaratumumabPhase 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) |
Who may qualify
- Ages
- Up to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaratumumabAlso: 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: 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA every 4 weeks (Stop at Day +270) | Drug | Interventional |
Primary outcome
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
1 secondary outcome
Relapse free survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Cairo, MD study chair
New York Medical College
Troy Quigg, DO study chair
Helen DeVos Children's Hospital
Allyson Flower, MD study chair
New York Medical College
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Harrison, RN, MSN (6172857844, lauren_harrison@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with dose limiting toxicity (per CTCAE v.5) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.