25 Participants Needed

Isatuximab for Immune Cytopenia After Stem Cell Transplant

Recruiting at 6 trial locations
MS
SG
Overseen BySergio Geralt, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Corticosteroids, IVIG, Rituximab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find out whether isatuximab is an effective treatment for people who developed immune cytopenias/ICs after allogeneic hematopoietic cell transplant/allo-HCT.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that growth factors like granulocyte colony stimulating factors and erythropoietin are allowed if administered at a stable dose. It's best to discuss your specific medications with the study team.

How is the drug Isatuximab different from other treatments for immune cytopenia after stem cell transplant?

Isatuximab is unique because it targets a different protein (CD38) on immune cells compared to Rituximab, which targets CD20. This difference in target proteins may offer an alternative approach for patients who do not respond well to existing treatments like Rituximab.12345

Who Is on the Research Team?

MS

Michael Scorder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults who have immune cytopenias after a stem cell transplant and haven't improved after at least two treatments, including steroids and rituximab. They must be in remission from the disease that required the transplant, not pregnant or willing to use birth control, free of active hepatitis or HIV, and able to give consent.

Inclusion Criteria

My condition didn't improve after trying at least 2 treatments including steroids, IVIG, or rituximab.
Patients with concomitant ICs can be enrolled on the study
Absolute neutrophil count (ANC) โ‰ฅ 1.0 x 10^9/L
See 9 more

Exclusion Criteria

I am able to understand and follow the study's requirements.
Pregnancy or unwillingness to agree to birth control
I am HIV positive or have an active hepatitis infection.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive isatuximab for treatment of refractory immune cytopenias after allo-HCT

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Isatuximab
Trial Overview The trial is testing Isatuximab's effectiveness for patients with persistent immune cytopenias following an allogeneic hematopoietic cell transplant. It aims to see if this drug can help where other treatments like corticosteroids have failed.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants with Refractory Immune CytopeniasExperimental Treatment1 Intervention

Isatuximab is already approved in European Union, United States for the following indications:

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Approved in European Union as Sarclisa for:
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Approved in United States as Sarclisa for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Rituximab was effective in treating autoimmune haemolytic anaemia (AIHA) and immune thrombocytopenia (ITP) in four patients after allogeneic stem cell transplantation, showing complete responses after conventional treatments failed.
This study suggests that autoimmune cytopenias, which were previously associated mainly with myeloablative conditioning, can also occur after reduced-intensity conditioning (RIC) regimens, indicating a need for awareness and better management strategies in these cases.
Rituximab is effective in the management of refractory autoimmune cytopenias occurring after allogeneic stem cell transplantation.Raj, K., Narayanan, S., Augustson, B., et al.[2015]
Rituximab, an anti-CD20 monoclonal antibody used for treating B-cell non-Hodgkin's lymphoma, has been associated with late-onset neutropenia, a condition where there is a dangerously low level of neutrophils, which are crucial for fighting infections.
This report highlights six cases of late-onset neutropenia occurring after stem cell transplantation, emphasizing the need for awareness and monitoring of this potential complication in patients receiving rituximab.
Rituximab-related late-onset neutropenia after autologous stem cell transplantation for aggressive non-Hodgkin's lymphoma.Lemieux, B., Tartas, S., Traulle, C., et al.[2015]
In a patient with late-onset neutropenia (LON) after rituximab treatment, the condition was linked to a lack of granulopoiesis in the bone marrow, rather than the presence of anti-neutrophil antibodies or other common causes of neutropenia.
High levels of BAFF (B-cell activating factor) were found, suggesting that excessive B-cell recovery may compete with granulocyte production in the bone marrow, indicating that monitoring BAFF levels could help identify patients at risk for developing LON.
Late-onset neutropenia following rituximab results from a hematopoietic lineage competition due to an excessive BAFF-induced B-cell recovery.Terrier, B., Ittah, M., Tourneur, L., et al.[2020]

Citations

Rituximab is effective in the management of refractory autoimmune cytopenias occurring after allogeneic stem cell transplantation. [2015]
Rituximab-related late-onset neutropenia after autologous stem cell transplantation for aggressive non-Hodgkin's lymphoma. [2015]
Late-onset neutropenia following rituximab results from a hematopoietic lineage competition due to an excessive BAFF-induced B-cell recovery. [2020]
High incidence of neutropenia in patients treated with rituximab after autologous stem cell transplantation. [2015]
Successful treatment of refractory autoimmune hemolytic anemia with monthly rituximab following nonmyeloablative stem cell transplantation for sickle cell disease. [2019]
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