Status:
UNKNOWN
Eltrombopag Treatment in Patients With Prolonged BM Toxicity After CART
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Novartis
Conditions:
CART Treatment
B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Treatment with chimeric antigen receptor-T cell (CAR-T) is successful in patients who have not responded to chemotherapy or bone marrow transplantation but it may provoke side effects and long-term co...
Detailed Description
CAR-T therapy is the standrad of care in patients with relapse/refractory B cell agressive lymphoproliferative diseases. Prolonged cytopenia is a not uncommon side effect and is associated with susbst...
Eligibility Criteria
Inclusion
- Willing to participate in the study and able to sign an informed consent form.
- Patients with B cell lymphoma or multiple myeloma who were treated with CART and demonstrated cytopenia on day 14 after CART administration. Cytopenia definition: absolute neutrophil count \<500 neutrophils/ul and/or platelets \<50,000 mm3
- Bone marrow demonstrates hypoplasia (cellularity less than 30%) 14 days after CART administration.
- \-
Exclusion
- Creatine \> 2.5 mg / dL
- Disorder in liver enzymes: bilirubin above 2 mg/dl , AST or ALT 5 times the normal.
- Active infection
- Active hemophagocytic syndrome
- Evidence of a viral or pharmacological disease that causes bone marrow injury
- Susceptibility to eltrombopag
- Evidence of disease in the bone marrow -
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05286164
Start Date
April 1 2022
End Date
April 1 2024
Last Update
April 15 2022
Active Locations (1)
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1
Tel-Aviv Sourasky Medicak center / BMT Unit
Tel Aviv, Israel, 6423906