Clinical trial for Hairy Cell Leukemia
Official title Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
ClinicalTrials.gov ID: NCT06965114
What this study is testing
What is Cladribine?
Cladribine is an investigational medicine, given as a once-weekly IV infusion (through a vein), being studied as a potential treatment for hairy cell leukemia.
Also referred to as 2-CdA, 2CDA.
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 phase I/II trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and compares the effect of tovorafenib and rituximab to current standard treatment of cladribine and rituximab in cHCL patients that have not yet received treatment. Tovorafenib blocks certain proteins made by the mutated BRAF gene, which may help keep cancer cells from growing.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- Which group you join is decided by chance.
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 histologically or cytologically confirmed diagnosis of classical hairy cell leukemia (HCL), including demonstration of BRAF V600E...
- PHASE 1 ONLY: Prior therapy with at least one purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine) unless...
- PHASE 2 ONLY: No prior HCL-directed treatment for front-line cohort.
- Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of tovorafenib (DAY101) or cladribine in combination...
- Absolute neutrophil count \< 1,000/mcL
You likely can't join if
- Central nervous system (CNS) involvement with HCL is very rare, and therefore the biology of the disease in patients with CNS involvement may not be...
- Patients with HCL who are BRAF V600E mutation negative and those with the variant HCL
- Patients with platelets \< 50,000/mCL
- Patients on warfarin and direct oral anticoagulants (due to risk of bleeding)
- Patients who have not recovered from AEs as a result of prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of...
- Patients who are receiving any other investigational agents
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed diagnosis of classical hairy cell leukemia (HCL), including demonstration of BRAF V600E mutation by immunohistochemistry, molecular diagnostic testing, or...
- PHASE 1 ONLY: Prior therapy with at least one purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine) unless contraindicated.
- PHASE 2 ONLY: No prior HCL-directed treatment for front-line cohort. The design of this cohort is such that the patients will need to be treatment naïve
- Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of tovorafenib (DAY101) or cladribine in combination with rituximab in patients \< 18 years of age, children are excluded...
- Absolute neutrophil count \< 1,000/mcL
- Platelets \< 100,000/mcL
- Hemoglobin \< 10 g/dL
- Recurrent infections
- Symptomatic and/or progressive extramedullary disease including lymph nodes and bone lesions
- Progressive or symptomatic splenomegaly or hepatomegaly
- Disease-related constitutional symptoms consisting of unexplained weight loss exceeding 10% body weight during the preceding 6 months, Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%); ECOG performance status \> 2 (Karnofsky \< 60%) will be allowed if considered due to HCL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN (unless related to Gilbert's disease...
- Creatinine clearance (ClCr) ≥ 30 mL/min
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of \< 480 msec
- The effects of tovorafenib (DAY101), cladribine, and rituximab on the developing human fetus are unknown.
- WOCBP should use effective non-hormonal contraception during treatment and for 12 months after the last dose of the study medication.
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LARs) may sign and give informed consent on behalf of study participants
- Central nervous system (CNS) involvement with HCL is very rare, and therefore the biology of the disease in patients with CNS involvement may not be representative of the disease under study as a whole.
- Patients with HCL who are BRAF V600E mutation negative and those with the variant HCL
- Patients with platelets \< 50,000/mCL
- Patients on warfarin and direct oral anticoagulants (due to risk of bleeding)
- Patients who have not recovered from AEs as a result of prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia
- Patients who are receiving any other investigational agents
- Patients who are receiving strong CYP2C8 inhibitors, inducers, and breast cancer resistance protein (BCRP) substrates with narrow therapeutic index
- Patients who are pregnant, breastfeeding, and/or unwilling to use adequate contraception during the study period and for 12 months after completion of the study
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to tovorafenib (DAY101) or other agents used in the study, including those with a previous history of...
- Patients with known hypersensitivity to any of the study drugs
- Patients with an inability to swallow oral medications or with gastrointestinal impairment
- Live or live-attenuated vaccines within 28 days of randomization
- 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 tovorafenib (DAY101) is a BRAF kinase inhibitor agent with the potential for teratogenic or abortifacient effects.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Charlottesville, Virginia, 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 16 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, United States; Charlottesville, Virginia, United States. 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.