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NCT01838395 · ClinicalTrials.gov registry record · Phase 2
Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
A Phase 2 study, sponsored by BioLineRx.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT01838395: Completed Phase 2 study, sponsored by BioLineRx.
NCT01838395 is a Phase 2 study that has completed, run by BioLineRx. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01838395, a Phase 2 study, has completed, sponsored by BioLineRx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
Primary Outcome
Number of participants with Adverse event affecting the safety and tolerability of BL-8040 + Ara-C by dose level (overall, dose limiting events, related Adverse Events (AEs), Serious Adverse Events (SAEs), related SAEs, AE by severity and death) Toxicity grade was assessed according to version V4.03 of NCI-CTCAE
Interventions
- DRUG Ara-C
- DRUG BL-8040
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-04 |
| Est. Completion | 2023-07-20 |
| Phase | Phase 2 |
What the finished NCT01838395 record still lists
NCT01838395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Ara-C is the first listed.
NCT01838395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01838395 about?
NCT01838395 is a clinical study titled "Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients". A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
What is the current status of trial NCT01838395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2013-04. Estimated completion is 2023-07-20.
What interventions are being tested in trial NCT01838395?
The interventions under investigation include: Ara-C (DRUG), BL-8040 (DRUG).
Who is sponsoring clinical trial NCT01838395?
This trial is sponsored by BioLineRx, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01838395's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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