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NCT03802695 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Orca Biosystems.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 9
- Study locations
NCT03802695: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Orca Biosystems.
NCT03802695 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Orca Biosystems. The registered enrollment target is 300 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (161% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03802695, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Orca Biosystems.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.
Primary Outcome
Safety and tolerability of Orca-Q (formerly OrcaGraft) in adults undergoing myeloablative allogeneic hematopoietic cell transplantation (MA-alloHCT) will be evaluated by identification of the following dose limiting toxicities: Grade ≥ 3 infusion-related reaction or cytokine release syndrome, Grade ≥ 3 acute GVHD, Any Grade ≥ 3 treatment-related non-hematologic event not clearly related to the underlying malignancy, intercurrent infection, the HCT conditioning regimen, or other pre-existing medi
Conditions Studied
Interventions
- BIOLOGICAL OrcaGraft (Orca-Q)
Study Locations (9)
California
- City of Hope - Duarte
- UC Davis - Sacramento
- Stanford Health Care - Stanford
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University - Atlanta
Kansas
- The University of Kansas Hospital - Kansas City
Ohio
- Ohio State University - Columbus
Texas
- University of Texas MD Anderson Cancer Center - Houston
Wisconsin
- Froedtert Memorial Lutheran Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT03802695 shows while recruiting
NCT03802695 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (161% higher).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which OrcaGraft (Orca-Q) is the first listed.
NCT03802695 lists 9 locations in 7 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT03802695 about?
NCT03802695 is a clinical study titled "A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies". This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.
What is the current status of trial NCT03802695?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2019-04-08. Estimated completion is 2027-12.
What conditions does trial NCT03802695 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia.
What interventions are being tested in trial NCT03802695?
The interventions under investigation include: OrcaGraft (Orca-Q) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03802695?
This trial is sponsored by Orca Biosystems, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03802695 being conducted?
This trial has 9 study locations across California, Florida, Georgia, Kansas, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03802695's enrollment target sits among peer trials
300 25th of 306 higher than 280 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid 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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