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NCT03817320 · ClinicalTrials.gov registry record · Phase 1
PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
A Phase 1 study of ALL, Childhood and Lymphoblastic Leukemia, Acute, Childhood, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 18
- Study locations
NCT03817320: Active Phase 1 study of ALL, Childhood and Lymphoblastic Leukemia, Acute, Childhood, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT03817320 is a Phase 1 study of ALL, Childhood and Lymphoblastic Leukemia, Acute, Childhood that is active but no longer recruiting, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 24 participants, below the 51-participant average among 4 other ALL, Childhood trials with a reported enrollment target (53% lower). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03817320, a Phase 1 study of ALL, Childhood and Lymphoblastic Leukemia, Acute, Childhood, is active but no longer recruiting, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).
Primary Outcome
The incidence of dose limiting toxicity (DLT) will be measured only during block 1
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Ixazomib
- DRUG Asparaginase
Study Locations (18)
Texas
- University of Texas, Southwestern - Dallas
- Cook Children's Medical Center - Fort Worth
- Texas Children's Hospital/Baylor University - Houston
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital Orange County - Orange
Ohio
- University Hospitals Seidman Cancer Center - Cleveland
- Nationwide Children's Hospital - Columbus
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Miami - Miami
Georgia
- Children's Healthcare of Atlanta - Atlanta
Michigan
- C.S. Mott Children's Hospital - Ann Arbor
Minnesota
- Children's Hospital and Clinics of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03817320 still lists
NCT03817320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 51-participant average among 4 other ALL, Childhood trials with a reported enrollment target (53% lower).
The record links to 3 conditions, with ALL, Childhood appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.
NCT03817320 lists 18 locations in 14 states (Texas, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT03817320 about?
NCT03817320 is a clinical study titled "PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma". This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).
What is the current status of trial NCT03817320?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-02-12. Estimated completion is 2025-06-30.
What conditions does trial NCT03817320 study?
This clinical trial studies the following conditions: ALL, Childhood, Lymphoblastic Leukemia, Acute, Childhood, Lymphoblastic Lymphoma, Childhood.
What interventions are being tested in trial NCT03817320?
The interventions under investigation include: Doxorubicin (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Ixazomib (DRUG), Asparaginase (DRUG).
Who is sponsoring clinical trial NCT03817320?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03817320 being conducted?
This trial has 18 study locations across California, District of Columbia, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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