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NCT05289687 · ClinicalTrials.gov registry record · Phase 2
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
A Phase 2 study of T-cell Acute Lymphoblastic Leukemia, sponsored by Eastern Cooperative Oncology Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05289687: Recruiting Phase 2 study of T-cell Acute Lymphoblastic Leukemia, sponsored by Eastern Cooperative Oncology Group.
NCT05289687 is a Phase 2 study of T-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Eastern Cooperative Oncology Group. The registered enrollment target is 20 participants, below the 60-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05289687, a Phase 2 study of T-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Eastern Cooperative Oncology Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.
Primary Outcome
Requires that all of the following be present. * Peripheral Blood Counts * Neutrophil count ≥ 1,000/µL. * Platelet count ≥ 100,000/µL. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Bone Marrow Aspirate and Biopsy * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines. * ≤ 5% T lymphoblasts by flow cytometry. * Extramedullary leukemia, such as CNS or soft tissue i
Conditions Studied
Interventions
- DRUG Daratumumab / Hyaluronidase Injection
Study Locations (1)
Illinois
- Northwestern - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-05-25 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT05289687 shows while recruiting
NCT05289687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 6 other T-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (67% lower).
The record links to 1 condition, with T-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab / Hyaluronidase Injection is the first listed.
NCT05289687 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05289687 about?
NCT05289687 is a clinical study titled "Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL". In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.
What is the current status of trial NCT05289687?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2023-05-25. Estimated completion is 2027-06-30.
What conditions does trial NCT05289687 study?
This clinical trial studies the following conditions: T-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05289687?
The interventions under investigation include: Daratumumab / Hyaluronidase Injection (DRUG).
Who is sponsoring clinical trial NCT05289687?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05289687 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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