A Phase 1 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
J
Jodi Skiles
Primary Investigator
Enrolling By Invitation
1 years - 39 years
All
Phase
1
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
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).
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
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the 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)
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: Riley, T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma
-
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
Updated on
07 Feb 2025.
Study ID: PHO-NYMC-ALLO-T-DART, 22996
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
