Loading clinical trials...

Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

NCT05873205•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years (There are no dosing/AE data for isatuximab in children).
•Disease for which patient underwent an allo-HCT is in documented remission.
•Patients must have previously had documented primary neutrophil and platelet engraftment, defined as:
•* Neutrophil engraftment: the first of 3 successive days with an absolute neutrophil count of ≥500/μL after post-transplantation nadir.
•* Platelet engraftment: the first of 3 consecutive days with a platelet count of 20,000/μL or higher in the absence of platelet transfusion for 7 consecutive days.
•Patients must be at least 45 days post allogeneic HCT to enroll.
•Patients must be diagnosed with IC(s) based on the following criteria:
•o For AIHA: Positive (abnormal) DAT test and decreasing hemoglobin of ≥2 g/dL from a stable baseline (i.e., from the patients typical hemoglobin value prior to AIHA) and at least grade 2 (i.e., hemoglobin \<10 g/dL) due to evidence of hemolytic anemia with ≥2 of the following tests: increased reticulocyte count (\>ULN), increased lactate dehydrogenase (LDH) (\>ULN), decreased haptoglobin (\<LLN), increased unconjugated bilirubin (\>ULN).
•DAT negative AIHA may be included providing exclusion of alternative etiology of hemolytic anemia.
•* For ITP: decreasing thrombocytopenia from baseline (i.e., from the patients typical platelet count prior to ITP) and platelet count ≤30 K/µL or requiring platelet transfusions in the absence of other causes of thrombocytopenia (including drug-induced thrombocytopenia), and with normal or increased bone marrow megakaryocytes.
+24 more criteria

Exclusion Criteria

•Presence of relapse/progression of malignant disease for which the patient underwent allo-HCT
•Patients with anemia and/or thrombocytopenia related to transplant-associated thrombotic microangiopathy.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States

Key Dates

Start Date

July 21, 2023

Primary Completion Date

June 29, 2026

Completion Date

June 29, 2026

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Blood CancerRefractory Immune Cytopenias

Interventions

Isatuximab

BIOLOGICAL

Contacts

Michael Scordo, MD

CONTACT

646-608-3771 scordom@mskcc.org

Sergio Geralt, MD

CONTACT

646-608-3731 GiraltS@mskcc.org

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

NCT07148180

Acute Myeloid Leukaemia (AML)Leukemia+2 more

View study

RECRUITING

Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut

NCT07305090

Blood Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

Inclusion Criteria

Exclusion Criteria

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut

Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years

Pharmacogenomics for Better Treatment of Fungal Infections in Cancer

European Rare Blood Disorders Platform (ENROL)

Understanding the Implementation of Cued Exercise Using Wearable Devices and a Custom Smartphone Application Following Bone Marrow Transplant.