Eltrombopag Treatment in Patients With Prolonged BM Toxicity After CART

NCT05286164 | Unknown Phase 2

• 1 other identifier: 0248-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 complications. Early and specific side effects include cytokine release syndrome and neurological toxicity. In addition, there are also late side effects. The most prominent of which is bone marrow damage and lack of recovery of blood counts after treatment. In this study, patients with prolong aplasia after CAR-T will recieve eltrombopag to enahnce bone marrow recovery.

Conditions

CART Treatment; B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• The percentage of cellularity

  Efficacy of eltrombopag treatment will be measured based on recovery of blood counts and recovery of bone marrow aplasia (measured as percentage of cellularity)

  up to 12 weeks (4 weeks from CART treatment and additional 8 weeks of treatment with eltrombopag)

• Identify the mechanism for the appearance of late bone marrow toxicity

  Identification of the mechanism for the CART- associated bone marrow aplasia will be based on cytokines profile, T cell subclasses analyses and single cell RNA sequencing. This will enable the investigators to shed more light on the pathologic process that connects CART cells admisnitration and bone marrow apasia.

  12 weeks from CART treatment

Study Arms (1)

Eltrombopag

EXPERIMENTAL

Patients with bone marrow aplasia for more than 30 days after CART treatment

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

Eltrombopag 150 mg QD for 8 weeks

Eltrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Novartis: collaborator

Study Sites (1)

Tel-Aviv Sourasky Medicak center / BMT Unit

Tel Aviv, 6423906, Israel

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ron Ram, Prof.

  Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Ram, Prof.

CONTACT

972-3-6947830; ronr@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients with bone marrow aplasia for more than 3 weeks after CART administration will receive eltrombopag treatment at a dose of 150 mg for 8 weeks.

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 18, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-03

Locations

IL (1)