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NCT04972942 · ClinicalTrials.gov registry record · Phase 1
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma
A Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 16
- Study locations
NCT04972942: Recruiting Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, sponsored by New York Medical College.
NCT04972942 is a Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 30 participants, below the 58-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (48% lower). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04972942, a Phase 1 study of T-cell Acute Lymphoblastic Leukemia and T-cell Acute Lymphoblastic Lymphoma, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab
Conditions Studied
Interventions
- DRUG Daratumumab
Study Locations (16)
California
- Loma Linda University Children's Hospital - Loma Linda
- University of California - Los Angeles
- University of California - San Francisco
Florida
- University of Florida - Gainsville
- John Hopkins All Children's Hospital - St. Petersburg
Arizona
- Phoenix Children's Hospital - Phoeniz
Colorado
- Children's Hospital Colordao - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Indiana
- Riley Children's Hospital - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- Helen DeVos Children's Hospital - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
What NCT04972942 shows while recruiting
NCT04972942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 58-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with T-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab is the first listed.
NCT04972942 lists 16 locations in 13 states (California, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT04972942 about?
NCT04972942 is a clinical study titled "Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma". 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 lymp...
What is the current status of trial NCT04972942?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-05-22. Estimated completion is 2028-09.
What conditions does trial NCT04972942 study?
This clinical trial studies the following conditions: T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT04972942?
The interventions under investigation include: Daratumumab (DRUG).
Who is sponsoring clinical trial NCT04972942?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04972942 being conducted?
This trial has 16 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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