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Phase 1/2 Dose Finding, Safety and Efficacy Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
EU CTIS ID: 2023-507330-24-00
What this study is testing
Part A - Dose Finding Study Primary Objective: To determine the recommended pediatric equivalent dose (RPED) (based on PK and, if applicable, pharmacodynamic data) for use in pediatric subjects (age ≥1 to <12 years) with cGVHD as defined by the 2014 NIH Consensus Development Project Criteria. Part B - Pharmacokinetics and Safety Study Primary Objective: To assess the PK and safety of ibrutinib in pediatric subjects (age ≥ 1 to < 22 years) with cGVHD.
- Phase I and Phase II (Integrated)- Other
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
- Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
- Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression. a. Subjects with new onset moderate or severe cGVHD must not have received previous systemic therapy for cGVHD with the exception of corticosteroids received within 72 hours prior to signing the informed consent form. b. Subjects with newly diagnosed cGVHD may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD, but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d at the time of enrollment.
- History of allogeneic stem cell transplantation
- Age • Part A: ≥1 to <12 years of age at the time of enrollment • Part B: ≥1 to <22 years of age at the time of enrollment
- Written informed consent or parental or guardian permission and assent of children capable of understanding the nature of the study, per country specific or site-specific standards.
- Ability of subject or, if a minor, parent/guardian to understand the purpose and risks of the study and to provide a signed and dated parental permission and authorization to use protected health information (in accordance with national and local subject privacy regulations); willingness of child to provide an assent, if developmentally able to do so.
You likely can't join if
- Presence of single organ genito-urinary involvement as the only manifestation of cGVHD. Concurrent Conditions
- Unwilling or unable to participate in all required study evaluations and procedures.
- Received an investigational agent within 28 days before enrollment.
- Received donor lymphocyte infusion (DLI) within 56 days before enrollment.
- Progressive underlying malignant disease or active post-transplant lymphoproliferative disease.
- Ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonist.
See the full eligibility criteria
- Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
- Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression. a. Subjects with new onset moderate or severe cGVHD must not have received previous systemic therapy for cGVHD with the exception of corticosteroids received within 72 hours prior to signing the informed consent form. b. Subjects with newly diagnosed cGVHD may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD, but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d at the time of enrollment.
- History of allogeneic stem cell transplantation
- Age • Part A: ≥1 to <12 years of age at the time of enrollment • Part B: ≥1 to <22 years of age at the time of enrollment
- Written informed consent or parental or guardian permission and assent of children capable of understanding the nature of the study, per country specific or site-specific standards.
- Ability of subject or, if a minor, parent/guardian to understand the purpose and risks of the study and to provide a signed and dated parental permission and authorization to use protected health information (in accordance with national and local subject privacy regulations); willingness of child to provide an assent, if developmentally able to do so.
- Presence of single organ genito-urinary involvement as the only manifestation of cGVHD. Concurrent Conditions
- Unwilling or unable to participate in all required study evaluations and procedures.
- Received an investigational agent within 28 days before enrollment.
- Received donor lymphocyte infusion (DLI) within 56 days before enrollment.
- Progressive underlying malignant disease or active post-transplant lymphoproliferative disease.
- Ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonist.
- History of other malignancy (not including the underlying malignancy that was the indication for transplant), with the following exceptions: • Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence by treating physician • Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease • Adequately treated cervical carcinoma in situ without current evidence of disease
- History of major surgery within 28 days before enrollment or lack of full recovery from surgery.
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
- Female subject who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months of the last dose of study drug. Male subject who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Russian Federation
- United Kingdom
- Australia
- United States
- Turkey
- Canada
- Israel
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Russian Federation; United Kingdom; Australia; United States; Turkey and 2 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 EU CTIS; the study team decides eligibility.