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VEMURAFENIB PLUS RITUXIMAB AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE FOLLOWED BY MRD-GUIDED RITUXIMAB IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIAL
EU CTIS ID: 2024-520119-41-00
What this study is testing
The primary objective of the trial is to show that the experimental therapy (VR) is no less effective and less toxic than the standard therapy (monotherapy with CDA).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Previously untreated patients with centrally reviewed diagnosis of HCL
- 10. No nausea, vomiting, malabsorption, external biliary shunt, significant bowel resection, or neurological disorder that would preclude adequate absorption. Patients must be able to swallow tablets.
- 11. No (suspected or documented) active uncontrolled serious infection, as defined by the presence of: i) febrile neutropenia (a single temperature of >38.3°C or a sustained temperature of =38°C for >1 hour) in a neutropenic patient (<1000 neutrophils x 109/L without G-CSF support), which has not resolved within =7 days from its onset despite anti-microbial therapy; and/or ii) a radiologically or clinically documented focus of infection (e.g., abscess, pneumonia, cellulitis, etc.) that has not been resolved by medical or surgical therapy.
- 12. Good renal function, as defined by creatinine clearance >50 ml/min.
- 13. Good hepatic function, as defined by a Child-Pugh score =6 (online calculator available for example at https://www.mdcalc.com/calc/340/child-pugh-score-cirrhosismortality), noting that abnormalities of each component of this score (e.g., bilirubin or INR) must be attributed to hepatic insufficiency and not to other causes (e.g., Gilbert syndrome or treatment with anti-coagulant drugs, respectively; in this case the abnormality unrelated to hepatic impairment is given the lowest score).
- 14. QTc interval < = 500 ms.
You likely can't join if
- 1.Concurrent administration of other any anti-cancer therapies. Prior splenectomy for diagnosis and/or therapy of HCL is not allowed.
- 2. Pregnancy or lactation.
- 3. Other active advanced cancer with projected life expectancy <1 year.
- 4. Cytopenias do not represent exclusion criteria as they are caused by HCL.
See the full eligibility criteria
Who can join
- 1. Previously untreated patients with centrally reviewed diagnosis of HCL
- 10. No nausea, vomiting, malabsorption, external biliary shunt, significant bowel resection, or neurological disorder that would preclude adequate absorption. Patients must be able to swallow tablets.
- 11. No (suspected or documented) active uncontrolled serious infection, as defined by the presence of: i) febrile neutropenia (a single temperature of >38.3°C or a sustained temperature of =38°C for >1 hour) in a neutropenic patient (<1000 neutrophils x 109/L without G-CSF support), which has not resolved within =7 days from its onset despite anti-microbial therapy; and/or ii) a radiologically or clinically documented focus of infection (e.g., abscess, pneumonia, cellulitis, etc.) that has not been resolved by medical or surgical therapy.
- 12. Good renal function, as defined by creatinine clearance >50 ml/min.
- 13. Good hepatic function, as defined by a Child-Pugh score =6 (online calculator available for example at https://www.mdcalc.com/calc/340/child-pugh-score-cirrhosismortality), noting that abnormalities of each component of this score (e.g., bilirubin or INR) must be attributed to hepatic insufficiency and not to other causes (e.g., Gilbert syndrome or treatment with anti-coagulant drugs, respectively; in this case the abnormality unrelated to hepatic impairment is given the lowest score).
- 14. QTc interval < = 500 ms.
- 2. Need of treatment, i.e. at least one of the following: neuthrophils <1x109 per liter, hemoglobin <10 g per deciliter, platelets <100x109 per liter, bulky/symptomatic splenomegaly, clinically relevant infiltration of other organs (e.g., lymphadenopathy), disease-related opportunistic infections or autoimmune disorders.
- 3. ECOG Performance Status of 0-2.
- 4. Male or female HCL patients > =18 years of age.
- 5. Negative serum pregnancy test within 14 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been post-menopausal (i.e., with an intact uterus, but with no mestrual bleeding for >=1 year in the absence of hormonal contraception).
- 6. Women of childbearing potential and men must use highly effective contraception methods during treatment, as well as for at least 6 months after treatment with cladribine or vemurafenib and at least 12 months after treatment with rituximab, including: intra-uterine devices or systems, hormonal implants or tube ligation for women; and vasectomy or condom for men. Oral contraceptives are not highly effective, also in light of potential drug-drug interaction. At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance [Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception]. Patients undergoing cladribine treatment should be counseled for fertilty preservation before cladribine treatment because of possible infertility due to cladribine therapy.
- 7. No medical, psychological, familial, sociological or geographical condition which may hamper compliance with the study protocol and follow-up schedule, or interfere with the interpretation of study results or would anyway make the patient inappropriate for enrollment in this study.
- 8. Signed informed consent (prior to performing any study-related procedures). After enrollment in the study, patients must also fulfill the following additional specific inclusion criteria for randomization to CDA+sR or VR:
- 9. BRAF-V600E mutation centrally confirmed.
What rules you out
- 1.Concurrent administration of other any anti-cancer therapies. Prior splenectomy for diagnosis and/or therapy of HCL is not allowed.
- 2. Pregnancy or lactation.
- 3. Other active advanced cancer with projected life expectancy <1 year.
- 4. Cytopenias do not represent exclusion criteria as they are caused by HCL.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.