Lymphoid Malignancies study: AVM0703
Official title The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
ClinicalTrials.gov ID: NCT04329728
What this study is testing
What is AVM0703?
This is an investigational medicine being studied as a potential treatment for lymphoid malignancies. is designed to be given as an intravenous infusion over about 1 hour.
Also referred to as Supra-Pharmacologic Dexamethasone Phosphate.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether AVM0703 is safe and how it behaves in the body. It also looks at early signs that it may fight cancer.
- Who it's for
- You may be able to join if you have a type of lymphoid cancer and are not in another trial.
- What's involved
- You will receive a single IV infusion of AVM0703. You may have blood tests and check‑ups to see how you feel and how the drug works.
- Time commitment
- The study lasts a few weeks, with a few visits for blood tests and health checks.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 95
You may be able to join if
- DLBCL, including arising from follicular lymphoma;
- High-grade B-cell lymphoma;
- MCL;
- Primary mediastinal large B-cell lymphoma;
- Primary DLBCL of the CNS;
You likely can't join if
- Adequately treated local basal cell or squamous cell carcinoma of the skin;
- Adequately treated carcinoma in situ without evidence of disease;
- Adequately treated papillary, noninvasive bladder cancer; or
- Other cancer that has been in complete remission for ≥2 years. Patients with low-grade prostate cancer, on active surveillance, and not expected to...
- Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to...
- Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter...
See the full eligibility criteria
- DLBCL, including arising from follicular lymphoma;
- High-grade B-cell lymphoma;
- MCL;
- Primary mediastinal large B-cell lymphoma;
- Primary DLBCL of the CNS;
- Burkitt or Burkitt-like lymphoma/leukemia;
- CLL/SLL; or
- DLBCL and high-grade B-cell lymphoma: e) R/R after autologous hematopoietic cell transplant (HCT); or f) R/R after chimeric antigen receptor T-cell (CAR T) therapy
- MCL: c) R/R after autologous HCT; or d) Patients not eligible for autologous HCT must have failed acalabrutinib or be R/R after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK)...
- Primary mediastinal large B-cell lymphoma: R/R after ≥1 line of therapy and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;
- Primary DLBCL of the CNS: R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no...
- Burkitt or Burkitt-like lymphoma/leukemia: R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or...
- CLL/SLL: patients who have active disease requiring treatment and who are deemed at high-risk for disease progression by the investigator or have high risk features per the iwCLL criteria, such as primary resistance to...
- B-cell lymphoblastic leukemia/lymphoma: ≥2 lines of therapy including approved CAR T cell therapies, inotuzumab ozogamicin, or blinatumomab, or for whom no standard therapy is available;
- T-cell lymphoblastic leukemia/lymphoma: ≥2 lines of therapy including nelarabine, or for whom no standard therapy is available;
- NK cell leukemia/lymphoma: ≥1 line of therapy or for whom no standard therapy is available;
- Absolute neutrophil count ≥0.05 × 109/L;
- Platelet count ≥25 × 109/L;
- Hemoglobin ≥6.5 g/dL;
- Aspartate aminotransferase or alanine aminotransferase ≥2.5 × ULN, unless due to the disease;
- Total bilirubin \<1.5 × ULN (if secondary to Gilbert's syndrome, \<3 × ULN is permitted), unless due to the disease; and
- Glomerular filtration rate ≥30 mL/min ; except for patients on metformin at baseline GFR must be ≥45 mL/min; GFR can be calculated by the Cockcroft-Gault formula Appendix C); 6\.
- Adequately treated local basal cell or squamous cell carcinoma of the skin;
- Adequately treated carcinoma in situ without evidence of disease;
- Adequately treated papillary, noninvasive bladder cancer; or
- Other cancer that has been in complete remission for ≥2 years. Patients with low-grade prostate cancer, on active surveillance, and not expected to clinically progress over 2 years are allowed;
- Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, angina requiring therapy...
- Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter, second degree atrioventricular (AV) block type 2, third-degree AV...
- Known gastric or duodenal ulcer;
- Uncontrolled type 1 or type 2 diabetes;
- Known hypersensitivity or allergy to the study drug or any of its excipients;
- Positive hepatitis B surface antigen and/or hepatitis B core antibody test plus a positive hepatitis B polymerase chain reaction (PCR) assay.
- Positive hepatitis C virus antibody (HCV Ab) test. Patients with a positive HCV Ab test are eligible if they are negative for hepatitis C virus by PCR;
- Positive human immunodeficiency virus (HIV) antibody test with detectable HIV load by PCR, or the patient is not able to tolerate antiretroviral therapy; or
- Positive tuberculosis test during screening; test must be positive and not indeterminate due to anergy
- Received live vaccination within 8 weeks of screening;
- Pregnant or breastfeeding;
- Concurrent participation in another therapeutic clinical study (except AVM0703-001); or
- Uncontrolled bipolar disorder or schizophrenia. Patients with a diagnosis, past or current, of bipolar disorder or schizophrenia or having a history of severe depression or substance abuse must be prophylactically...
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- Whittier, California, United States
- Weeki Wachee, Florida, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Omaha, Nebraska, United States
- Canton, Ohio, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; Whittier, California, United States; Weeki Wachee, Florida, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.