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NCT05192889 · ClinicalTrials.gov registry record · Phase 1
Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
A Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Relapsed Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT05192889: Active Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Relapsed Acute Lymphoblastic Leukemia, sponsored by St. Jude Children's Research Hospital.
NCT05192889 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Relapsed Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 35 participants, below the 43-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (19% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05192889, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Relapsed Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations with either blinatumomab for CD19-positive patients or navitoclax and high-dose cytarabine for CD19-negative patients. Primary Objectives * To compare Minimal Residual Disease (MRD)-negative CR/CRi rate in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) following Block 1 therapy with venetoclax and navitoclax based reinduction to historical controls. * To identify the recommended phase 2 combination dose (RP2D) of venetoclax based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab. Secondary Objectives * To estimate the tolerability and activity of venetoclax based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab. * To describe event-free and overall survival in patients treated with this regimen. Exploratory Objectives * To evaluate MRD-negative CR/CRi rates in each prespecified groups: late first relapse B-ALL; early first relapse and second or greater relapse B-ALL; and relapsed T-ALL. * To identify drug sensitivity patterns in patient samples prior to and after receiving combination therapy and evaluate mechanisms of disease resistance/ escape. * To explore immune subsets during and after this regimen. * Evaluate response to therapy in rare relapse patient subsets. * Explore breakthrough infections in children and young adults with relapsed or refractory ALL
Primary Outcome
The number of participants with end Block 1 minimal residual disease \<0.01% by flow cytometry
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Calaspargase Pegol
- DRUG Navitoclax
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center - New York
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What the registry record for NCT05192889 still lists
NCT05192889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 43-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (19% lower).
The record links to 2 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT05192889 reports a single indexed study location in New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05192889 about?
NCT05192889 is a clinical study titled "Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax". This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations with either blinatumomab for CD...
What is the current status of trial NCT05192889?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2022-08-25. Estimated completion is 2027-02.
What conditions does trial NCT05192889 study?
This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05192889?
The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Calaspargase Pegol (DRUG), Navitoclax (DRUG).
Who is sponsoring clinical trial NCT05192889?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05192889 being conducted?
This trial has 2 study locations across New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05192889's enrollment target sits among peer trials
35 10th of 21 higher than 12 of 21 other Refractory Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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