A Phase 1b/2 Trial of Targeted Immunotherapy with Daratumumab Following Myeloablative Total Body Irradiation (TBI)-Based Conditioning and Allogeneic Hematopoietic Cell Transplantation in Children, Adolescents and Young Adults with High-Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma

Investigating Immunotherapy After Transplant in Young Patients with T-Cell Leukemia and Lymphoma

Primary Investigator
J
Jodi Skiles

Primary Investigator

Enrolling By Invitation
1 years - 39 years
All
Phase 1/2
1 participants needed
1 Location

Brief description of study

A Phase 1b/2 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).
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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.

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)

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma, Cancer
  • Age: 1 years - 39 years
  • Gender: All

Inclusion Criteria:

  •  T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy
  • 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

This study investigates an immunotherapy treatment for children, adolescents, and young adults with high-risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). The purpose of this study is to determine the safety of using an investigational medication after a procedure called total body irradiation (TBI) and a type of transplant called allogeneic hematopoietic cell transplantation (HCT). T-ALL is a type of cancer that affects white blood cells, and T-LLy is a similar type of cancer that forms in the lymphatic system.

Participants in this study will receive the investigational medication through an IV in three phases: induction, consolidation, and maintenance. In the induction phase, the medicine is given weekly for 8 weeks. During the consolidation phase, it is given every 2 weeks for 8 doses, and in the maintenance phase, it is administered every 4 weeks until Day 270. The study will also involve checking how the immune system responds to the treatment.

  • Who can participate: Children, adolescents, and young adults with T-cell acute lymphoblastic leukemia in their second or later remission, or with relapsed T-cell lymphoblastic lymphoma who have fully responded to re-induction therapy, may participate. Participants must have a planned allogeneic stem cell transplant, meet specific health criteria, and have signed informed consent.
  • Study details: Participants will receive an investigational medication through an IV following a transplant procedure. The study will monitor the safety and effects of the treatment on the immune system. A placebo is not used in this study.
Updated on 18 Aug 2026. Study ID: 22996
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only