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Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
NCT04972942 · New York Medical College
In plain English
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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)
About this study
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:
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)
Eligibility criteria
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 target: 30 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2023-05-22
Estimated completion: 2028-09
Last updated: 2026-04-15
Interventions
Drug: Daratumumab
Primary outcomes
- • Patients with dose limiting toxicity (per CTCAE v.5) (60 days)
Sponsor
New York Medical College · other
Contacts & investigators
ContactLauren Harrison, RN, MSN · contact · lauren_harrison@nymc.edu · 6172857844
ContactErin Morris, RN · contact · erin_morris@nymc.edu · 7149645359
InvestigatorMitchell Cairo, MD · study_chair, New York Medical College
InvestigatorTroy Quigg, DO · study_chair, Helen DeVos Children's Hospital
InvestigatorAllyson Flower, MD · study_chair, New York Medical College
All locations (16)
Phoenix Children's HospitalNot Yet Recruiting
Phoeniz, Arizona, United States
Loma Linda University Children's HospitalRecruiting
Loma Linda, California, United States
University of CaliforniaNot Yet Recruiting
Los Angeles, California, United States
University of CaliforniaRecruiting
San Francisco, California, United States
Children's Hospital ColordaoNot Yet Recruiting
Aurora, Colorado, United States
Children's National Medical CenterNot Yet Recruiting
Washington D.C., District of Columbia, United States
University of FloridaRecruiting
Gainsville, Florida, United States
John Hopkins All Children's HospitalNot Yet Recruiting
St. Petersburg, Florida, United States
Riley Children's HospitalRecruiting
Indianapolis, Indiana, United States
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
Helen DeVos Children's HospitalRecruiting
Grand Rapids, Michigan, United States
New York Medical CollegeRecruiting
Vallhala, New York, United States
Nationwide Children's HosptialNot Yet Recruiting
Columbus, Ohio, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
Medical College of WisconsinNot Yet Recruiting
Milwaukee, Wisconsin, United States