A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)

NCT05284032 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: HSR210463
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Some of the treatments for cancer can cause platelets (the part of the blood that helps with clotting) to decrease. If they are too low, then clinicians may recommend a transfusion (getting platelets from another person added to someone else's body). This usually works to increase the person's platelets to a healthy level, but sometimes it doesn't work. This is called platelet refractoriness. This study is trying to find out whether isatuximab (the study drug) may help people with a certain type of platelet refractoriness by removing some cells in order to make platelet transfusions more effective.

Conditions

Platelet Refractoriness; Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Percent panel-reactive antibodies (PRAs)- change over time/with study treatment

  A weighted percent of class I HLA targets to which the patient has made antibodies

  Through about 120 days following last study drug infusion

Secondary Outcomes (3)

• Mean fluorescence intensity (MFI) - change over time/ with study treatment

  Through about 120 days following last study drug infusion

• Quality of life - changes over time/with study treatment according to the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu)

  Through about 120 days following last study drug infusion

• Adverse events

  Through about 30 days following last study drug infusion

Study Arms (1)

Isatuximab (Sarclisa)

EXPERIMENTAL

4 weekly doses of isatuximab

Drug: isatuximab 10 mg/kg

Interventions

isatuximab 10 mg/kg DRUG

Given by intravenous infusion

Isatuximab (Sarclisa)

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age ≥ 18 years
• Diagnosis of immune mediated platelet transfusion refractoriness secondary to class I anti-HLA antibodies according to institutional practice, including calculated percent panel-reactive antibodies (%PRA) \> 80%
• Adequate Organ Function:
• serum creatinine \<= 1.5 x upper limit of normal
• bilirubin \<= 1.5 x upper limit of normal (exceptions for Gilbert's disease)
• AST and ALT \<= 2.5 x upper limit of normal
• Alkaline phosphatase \<= 2.5 x upper limit of normal
• For females and males of reproductive potential: agreement to use adequate contraception (see section 5.3)
• Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration

You may not qualify if:

• Immune-mediated platelet refractoriness other than anti-HLA antibody-mediated
• Non-immune-mediated platelet refractoriness (e.g. splenomegaly or disseminated intravascular coagulation)
• Diagnosis of thrombocytopenia induced by other drugs, such as vancomycin, heparin, or amphotericin
• Diagnosis of thrombotic thrombocytopenic purpura or idiopathic immune thrombocytopenia
• Active bleeding
• Greater than Grade 2 active graft versus host disease (GVHD) following allogeneic HSCT
• Bi-directional ABO mismatched allogeneic stem cell transplantation
• Prior administration of daratumumab, isatuximab or any other anti-CD38 antibodies
• Known uncontrolled HIV disease and/or active Hepatitis A, B, or C infection
• Active systemic infection and severe infections requiring treatment with a parenteral administration of antimicrobials.
• Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
• Received any investigational drug within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention, whichever is longer. In case of very aggressive disease (i.e acute leukemia) delay could be shortened after agreement between sponsor and investigator, in absence of residual toxicities from previous therapy
• Pregnancy or lactation
• Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results.
• Current receipt of, or expectation to require anti-CD20 therapy, proteasome inhibitors, intravenous immune globulin ("IVIG"), and plasma exchange therapy during the study

Sponsors & Collaborators

• Firas El Chaer, MD: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Firas El Chaer, MD

  UVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: November 29, 2022
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)