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NCT03564678 · ClinicalTrials.gov registry record · Phase 2
Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03564678: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03564678 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03564678, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial studies how well levocarnitine and vitamin B complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with PEG-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. Amino acids, such as levocarnitine, may work in normalizing liver enzyme levels due to treatment. Vitamin B complex is a dietary supplement that may be used for patients with nutritional deficiencies. Giving levocarnitine and vitamin B complex may work better in treating hyperbilirubinemia in patients with acute lymphoblastic leukemia.
Primary Outcome
Normalization of hyperbilirubinemia (Total bilirubin \< 1.5 x ULN) or at least 50% reduction in peak total bilirubin within 11 days.
Interventions
- DIETARY_SUPPLEMENT Levocarnitine
- DRUG Vitamin B Complex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2024-10-15 |
| Phase | Phase 2 |
Why NCT03564678 stopped before completion
NCT03564678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Levocarnitine is the first listed.
NCT03564678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03564678 about?
NCT03564678 is a clinical study titled "Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia". This phase II trial studies how well levocarnitine and vitamin B complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with PEG-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. Amino acids, such as levocarnitine, may ...
What is the current status of trial NCT03564678?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-05-17. Estimated completion is 2024-10-15.
What interventions are being tested in trial NCT03564678?
The interventions under investigation include: Levocarnitine (DIETARY_SUPPLEMENT), Vitamin B Complex (DRUG).
Who is sponsoring clinical trial NCT03564678?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03564678's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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