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New treatment option for Immune Thrombocytopenia
Official title Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT06838962
What this study is testing
What is Daratumumab Injection?
Daratumumab Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for immune thrombocytopenia.
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
- To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of primary immune thrombocytopenia in patients who have failed first-line treatment.
- 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 6 to 18
You may be able to join if
- Age ≥6 years, ≤18 years, male or female.
- Before enrollment, the people have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the...
- Patients have failed glucocorticoid therapy (either due to inefficacy, how well it works could not be maintained, or relapse). Patients should have a...
- Platelet count \ 35×10\^9/L.
- ECOG performance status score of ≤2.
You likely can't join if
- Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or...
- All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.
- Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage...
- Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is...
- Patients taking antiplatelet drugs within 3 weeks before the first dose.
- people who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or...
See the full eligibility criteria
Who can join
- Age ≥6 years, ≤18 years, male or female.
- Before enrollment, the people have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice...
- Patients have failed glucocorticoid therapy (either due to inefficacy, how well it works could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy...
- Platelet count \ 35×10\^9/L.
- ECOG performance status score of ≤2.
- Enrollment of people receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists. Only one concomitant medication was allowed at the time of...
- For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4/6 months after the cessation of study...
- people comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.
What rules you out
- Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.
- All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.
- Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12...
- Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.
- Patients taking antiplatelet drugs within 3 weeks before the first dose.
- people who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first...
- people who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. people who have receive anti-CD20...
- people who have undergone splenectomy within 6 months prior to the first dose of study drug.
- people who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.
- people who are diagnosed with Myelodysplastic syndromes (MDS); people with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin...
- people who have undergone allogeneic stem cell transplantation or organ transplantation.
- people with a clinically significant medical history, as perceived by investigators, that will pose risks to people' safety during the study or potentially affect the safety or how well it works analyses, includes major...
- people with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4...
- people with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the...
- Significant laboratory abnormalities during screening included:
- Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).
- Total bilirubin greater than 1.5 times the ULN (note: people diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).
- absolute neutrophil count \< 1500/mm3.
- hemoglobin \< 9g/dL; IgG \< 500 mg/dL.
- lymphocyte count \< 500/mm3.
- Creatinine clearance (CrCl) \< 30 mL/min (i.e., CrCl ≥30 mL/min is allowed)
- Positive for HIV antibodies or syphilis antibodies.
- people test positive for Hepatitis B surface antigen (HBsAg) or people test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or people test positive for hepatitis C virus...
- Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.
- Any other conditions unsuitable for participation in this study, as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
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, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. 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.