The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
Part of paid clinical trials in Duarte, California.
- Sponsor
- AVM Biotechnology Inc
- Study ID
- NCT04329728
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Lymphoid Malignancies
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 95 Years
- Healthy Volunteers
- Not accepted
Interventions
- AVM0703 — DRUGIntravenous infusion over \~1 hours
Study Details
This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.
Key Dates
- Start date
- Nov 6, 2020
- Status verified
- Apr 2026
- Primary completion
- Nov 30, 2027
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 144 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DLBCL and high-grade B-cell lymphomaDiffuse Large Cell B-Lymphoma High-grade B-cell Lymphoma
- Experimental: MCL (Chronic Lymphoid Leukemia)Chronic Lymphoid Leukemia
- Experimental: Primary Mediastinal Large B-cell lymphomaPrimary mediastinal large B-cell lymphoma
- Experimental: Burkitt or Burkitt-like lymphoma/leukemiaBurkitt or Burkitt-like lymphoma/leukemia
- Experimental: CLL/SLLChronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
- Experimental: B- or T-ALLB-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or natural killer (NK) cell lymphoblastic leukemia/lymphoma
Primary Outcome Measure
Phase 1: incidence of Adverse events [ Time Frame: Year One ]
Central Contacts
- Theresa Deisher, PhD206-851-3942
- Sandeep Mittal, PhD346-401-4303
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Ricardo Ortega Elizabeth Budde (PRINCIPAL_INVESTIGATOR) |
| Los Angeles Cancer Network | Los Angeles | California | 90017 | Lasika Seneviratne (PRINCIPAL_INVESTIGATOR) |
| UCLA Medical Center of Hematology/Oncology | Los Angeles | California | 90095 | Gary J Schiller (PRINCIPAL_INVESTIGATOR) |
| Innovative Clinical Research Institute | Whittier | California | 92705 | Pamela Miel, MD |
| ASCLEPES Research Centers | Weeki Wachee | Florida | 34613 | |
| University of Illinois at Chicago Cancer Center | Chicago | Illinois | 60612 | |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | Don Stevens, MD (PRINCIPAL_INVESTIGATOR) |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68124 | Stefano Tarantolo, MD (PRINCIPAL_INVESTIGATOR) Ryan Ramaekers, MD (SUB_INVESTIGATOR) |
| Gabrail Cancer Center Research, | Canton | Ohio | 44718 | |
| Baptist Clinical Research Institute | Memphis | Tennessee | 38120 | Lauren Wooten Salil Goorha (PRINCIPAL_INVESTIGATOR) |
| University of Texas(UT) Southwestern-Children's Medical Center | Dallas | Texas | 75235 | Teresa Banda Slone Tamra (PRINCIPAL_INVESTIGATOR) |
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