This study is NOT currently recruiting participants.
Number
002029-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Fetuses;Neonates;Pregnant Women
Keywords
Minimal Residual Disease; B-cell lymphoma 2; BCL-2 Inhibitor
Recruitment Keyword(s)
None
Condition(s)
Hairy Cell Leukemia; Hairy Cell Leukemia Variant
Investigational Drug(s)
venclexta
Investigational Device(s)
Intervention(s)
Drug: Venetoclax
Supporting Site
National Cancer Institute
Hairy cell leukemia (HCL) is a blood cancer that affects white blood cells called B cells. This disease often comes back after current treatments. Venetoclax is a drug approved by the FDA to treat other cancers. Researchers want to know if this drug can help people with HCL, too.
Objective:
To test venetoclax in people with HCL.
Eligibility:
People aged 18 years and older with HCL.
Design:
Before participants begin taking venetoclax, they will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans.
Venetoclax is a tablet taken by mouth. Participants will take the drug once a day, every day, at home. Their dose will increase each week for the first 5 weeks. They will have blood tests each week during the first 5 weeks of treatment. They will continue taking the highest dose unless they have adverse effects from the drug; then they may drop back to a lower dose. They will write down when they take each tablet in a diary.
Participants will continue taking venetoclax for a total of 19 cycles. Each cycle is 28 days.
Participants will have clinic visits or phone calls every 2 to 3 months during treatment. Physical exams, blood tests, and imaging scans will be repeated at different times.
Participants will be monitored for adverse effects for 30 days after treatment ends.
--Back to Top--
INCLUSION CRITERIA: -Patients must have histologically or cytologically confirmed HCL/HCLv after purine analog therapy who are relapsed from or are ineligible for BRAFtherapy and have not received prior venetoclax. -Age >=18 years. -ECOG performance status <=2 (Karnofsky >=60%). -Patients must have adequate organ and marrow function as defined below: --total bilirubin <= 3x institutional upper limit of normal (ULN) unless consistent with Gilbert s (ration between total and direct bilirubin >5) --AST(SGOT)/ALT(SGPT) <=3 x institutional ULN --serum creatinine <= 2.0 mg/dL OR --creatinine clearance >= 45 mL/min/1.73m^2 -Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. -For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. -Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. -Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. -Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. -Patients must have had no HCL/HCLv treatment for >= 4 weeks prior to enrollment, and those with treatment > 4 weeks prior to enrollment must not be responding to their last treatment with decreasing tumor burden or improving drug-related cytopenias. -Patients must have a need for treatment due to ANC <1/nL, Hgb <10g/dL, Plt < 100/nL, symptomatic splenomegaly, enlarging HCL mass >2cm in short axis, enlarging HCL mass >0.5 cm in the CNS in short axis, or leukemic count >5/nL. -The effects of venetoclax on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during treatment and for 30 days after the last dose of venetoclax. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception during treatment and for 30 days after the last dose of venetoclax. -Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. -Ability and willingness to swallow pills. EXCLUSION CRITERIA: -Patients who have received prior venetoclax. -Patients who are receiving any other investigational agents. -History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax. -Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous. -Pregnant women are excluded from this study because venetoclax is a B-cell lymphoma-2 (BCL-2) inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. -Malabsorption syndrome or other conditions that would interfere with intestinal absorption. -Live attenuated vaccines should not be administered within 4 weeks prior to, during, or 30 days after study treatment and recovery has occurred.
-Patients must have histologically or cytologically confirmed HCL/HCLv after purine analog therapy who are relapsed from or are ineligible for BRAFtherapy and have not received prior venetoclax.
-Age >=18 years.
-ECOG performance status <=2 (Karnofsky >=60%).
-Patients must have adequate organ and marrow function as defined below:
--total bilirubin <= 3x institutional upper limit of normal (ULN) unless consistent with Gilbert s (ration between total and direct bilirubin >5)
--AST(SGOT)/ALT(SGPT) <=3 x institutional ULN
--serum creatinine <= 2.0 mg/dL
OR
--creatinine clearance >= 45 mL/min/1.73m^2
-Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
-For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
-Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
-Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
-Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
-Patients must have had no HCL/HCLv treatment for >= 4 weeks prior to enrollment, and those with treatment > 4 weeks prior to enrollment must not be responding to their last treatment with decreasing tumor burden or improving drug-related cytopenias.
-Patients must have a need for treatment due to ANC <1/nL, Hgb <10g/dL, Plt < 100/nL, symptomatic splenomegaly, enlarging HCL mass >2cm in short axis, enlarging HCL mass >0.5 cm in the CNS in short axis, or leukemic count >5/nL.
-The effects of venetoclax on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during treatment and for 30 days after the last dose of venetoclax. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception during treatment and for 30 days after the last dose of venetoclax.
-Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
-Ability and willingness to swallow pills.
EXCLUSION CRITERIA:
-Patients who have received prior venetoclax.
-Patients who are receiving any other investigational agents.
-History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax.
-Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
-Pregnant women are excluded from this study because venetoclax is a B-cell lymphoma-2 (BCL-2) inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.
-Malabsorption syndrome or other conditions that would interfere with intestinal absorption.
-Live attenuated vaccines should not be administered within 4 weeks prior to, during, or 30 days after study treatment and recovery has occurred.
Principal Investigator
Referral Contact
For more information: