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New treatment option for Lymphoid Malignancies
Official title The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
ClinicalTrials.gov ID: NCT04329728
What this study is testing
What is AVM0703?
AVM0703 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lymphoid malignancies.
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 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.
- 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
- 1\. Age ≥12 years and weight ≥40 kg; 2\. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid...
- DLBCL, including arising from follicular lymphoma;
- High-grade B-cell lymphoma;
- MCL;
- Primary mediastinal large B-cell lymphoma;
You likely can't join if
- Patients who meet any of the following criteria will be excluded from participation in the study for Phase 2:
- History of another malignancy, except for the following:
- 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...
See the full eligibility criteria
Who can join
- 1\. Age ≥12 years and weight ≥40 kg; 2\. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid neoplasms160 and per the 2016 WHO classification of acute leukemia161 of...
- 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
- B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or NK cell lymphoblastic leukemia/lymphoma; 3\. Patients must have relapsed 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; or g) Patients not eligible for autologous HCT or CAR...
- 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...
- Acute lymphoblastic leukemia (ALL): c) R/R after allogeneic HCT and for whom no standard therapy is available; or d) Patients not eligible for allogeneic HCT must be R/R according to the following disease specific...
- 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;
- All other diagnoses: R/R after autologous or allogeneic HCT; or R/R after at least one line of therapy, or for whom no standard therapy is available. 4\. Lansky (12 to 15 years of age) (Appendix G) or Karnofsky (≥16...
- 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\. Minimum level of pulmonary reserve...
What rules you out
- Patients who meet any of the following criteria will be excluded from participation in the study for Phase 2:
- History of another malignancy, except for the following:
- 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;
- Untreated ongoing bacterial, fungal, or viral infection (including upper respiratory tract infections) at the start of AVM0703 administration, including the following:
- Positive hepatitis B surface antigen and/or hepatitis B core antibody test plus a positive hepatitis B polymerase chain reaction (PCR) assay. Patients with a negative PCR assay are permitted with appropriate antiviral...
- 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; if the result is indeterminate due to anergy the patient must not have a history of recent exposure to...
- 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.