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New treatment option for Chronic Lymphocytic Leukemia
Official title Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
ClinicalTrials.gov ID: NCT03128879
What this study is testing
What is Ibrutinib?
Ibrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as BTK Inhibitor PCI-32765, CRA-032765.
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 a single center, open-label, phase II study of venetoclax (ABT-199) added to ibrutinib or acalabrutinib in patients with high-risk CLL who have received at least 12 months of ibrutinib or acalabrutinib monotherapy. The study will estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable CLL after receiving ibrutinib or acalabrutinib for at least 12 months and who have high risk CLL.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have a diagnosis of CLL/CLL and have high-risk cytogenetic features or molecular features, defined as: del(17p), mutated TP53, complex...
- Patients must have received at least 12 months of ibrutinib or acalabrutinib therapy and have measurable CLL by at least one of the following:
- Absolute monoclonal lymphocyte count \> 4000/L; OR
- Measurable lymph nodes with at least one node \>1.5 cm in diameter on CT; OR
- Bone marrow with \>/= 30% lymphocytes on aspirate differential OR
You likely can't join if
- Richter transformation.
- Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri...
- Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study...
- Grade 3 or 4 hemorrhage within the past 3 weeks.
- Uncontrolled active infections (viral, bacterial, and fungal).
- Females who are pregnant or lactating.
See the full eligibility criteria
- Patients must have a diagnosis of CLL/CLL and have high-risk cytogenetic features or molecular features, defined as: del(17p), mutated TP53, complex metaphase karyotype (defined as 3 unrelated chromosomal abnormalities...
- Patients must have received at least 12 months of ibrutinib or acalabrutinib therapy and have measurable CLL by at least one of the following:
- Absolute monoclonal lymphocyte count \> 4000/L; OR
- Measurable lymph nodes with at least one node \>1.5 cm in diameter on CT; OR
- Bone marrow with \>/= 30% lymphocytes on aspirate differential OR
- Detectable CLL cells using a standardized flow cytometry assay for minimal residual disease
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Patients must have adequate renal and hepatic function:
- Serum bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease.
- Serum creatinine clearance of 50ml/min (calculated or measured).
- ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement.
- Adequate bone marrow function:
- Platelet count of greater than 50,000/µl, with no platelet transfusion in prior 2 weeks.
- ANC ≥1000/µl in the absence of growth factor support unless due to compromised bone marrow production from CLL, indicated by 80% CLL in marrow.
- Hemoglobin ≥8mg/dL.
- INR \<1.5.
- Adequate cardiac function, as assessed by:
- Absence of uncontrolled cardiac arrhythmia.
- Echocardiogram demonstrating LVEF ≥35%.
- NYHA functional class ≤2.
- Ability to provide informed consent and adhere to the required follow-up.
- Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use use both a...
- Patients or their legally authorized representative must provide written informed consent.
- Richter transformation.
- Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma...
- Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drug.
- Grade 3 or 4 hemorrhage within the past 3 weeks.
- Uncontrolled active infections (viral, bacterial, and fungal).
- Females who are pregnant or lactating.
- Known positive serology for human immunodeficiency virus (HIV).
- Active hepatitis B infection (defined as the presence of detectable HBV DNA or HBe antigen). Patients who are HBsAg positive or HBcAb positive are eligible, provided HBV DNA is negative. These patients will have monthly...
- Active hepatitis C, defined by the detection of hepatitis C RNA in plasma by PCR.
- Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy \>20mg prednisone daily or equivalent, within 7 days of starting venetoclax.
- Received other investigational therapeutic agent for CLL/SLL within 21 days of starting venetoclax.
- Concurrent use of warfarin.
- Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting venetoclax.
- Consuming grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting venetoclax.
- Prior treatment with venetoclax or other Bcl-2 inhibitor.
- Malabsorption syndrome or other condition that precludes enteral route of administration
The study team makes the final eligibility decision.
Where it's taking place
- Houston, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.