Recruiting
Phase 1

Targeted Immunotherapy

Sponsor:

New York Medical College

Code:

NCT04972942

Conditions

T-cell Acute Lymphoblastic Leukemia

T-Cell Acute Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Not accepted

Interventions

Daratumumab

Study Details

Brief 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 (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

T-cell Acute Lymphoblastic Leukemia

T-Cell Acute Lymphoblastic Lymphoma

Study ID

NCT04972942

Start date

May 22, 2023

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Interventional

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)

Interventions

Daratumumab

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)

Primary outcome measure

  • Patients with dose limiting toxicity (per CTCAE v.5) [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Lauren Harrison, RN, MSN

6172857844lauren_harrison@nymc.edu

Erin Morris, RN

7149645359erin_morris@nymc.edu

Locations

Loma Linda University Children's Hospital

Recruiting

Loma Linda, California, United States, 92354

Contacts

Hisham Abdel-Azim, MD

(909) 558-4076habdelazim@llu.edu

University of California

Recruiting

San Francisco, California, United States, 94143

University of Florida

Recruiting

Gainsville, Florida, United States, 32608

Contacts

Jordan Milner, MD

(352) 273-9120jordan.milner@peds.ufl.edu

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

April Rahrig, MD

(260) 227-0353alrahrig@iu.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Amy Keating, MD

(857) 215-2881amy_keating@dfci.harvard.edu

Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Troy Quigg, DO

(616) 391-3962troy.quigg@corewellhealth.org

New York Medical College

Recruiting

Vallhala, New York, United States, 10595

Contacts

Mitchell Cairo, MD

914-594-3650mitchell_cairo@nymc.edu

Lauren Harrison, MSN

617-285-7844lauren_harrison@nymc.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alix Seif, MD

(215) 590-9996seifa@chop.edu

More Information

Sponsor

New York Medical College

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • immunotherapy
  • children
  • adolescents
  • young adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by New York Medical College on 2026-04-15.