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NCT04747912 · ClinicalTrials.gov registry record · Phase 2
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
A Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Leukemia, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04747912: Recruiting Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Leukemia, sponsored by University of Chicago.
NCT04747912 is a Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Leukemia that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 25 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04747912, a Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Leukemia, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.
Primary Outcome
Complete clinical remission (when there are no signs of the disease) with a major molecular remission at 60 days as defined by participants who have a low ratio (less than or equal to .01%) of BCR-ABL1gene in their blood, according to criteria set by the International Scale for p210 BCR-ABL1.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Dasatinib
- DRUG Methotrexate
- DRUG Inotuzumab ozogamicin
Study Locations (1)
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What NCT04747912 shows while recruiting
NCT04747912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT04747912 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04747912 about?
NCT04747912 is a clinical study titled "Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)". This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard inducti...
What is the current status of trial NCT04747912?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2021-03-02. Estimated completion is 2027-03-01.
What conditions does trial NCT04747912 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia, ph+ Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT04747912?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Dasatinib (DRUG), Methotrexate (DRUG), Inotuzumab ozogamicin (DRUG).
Who is sponsoring clinical trial NCT04747912?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04747912 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04747912's enrollment target sits among peer trials
25 99th of 131 higher than 32 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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