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RecruitingLast updated: 2 February 2024

EQUATOR: This phase III study is evaluating how safe and effective targeted therapy (itolizumab) is, compared to a placebo, in people with acute graft versus host diseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive itolizumab administered by intravenous infusion every two weeks for a total of 7 doses. In the Placebo Comparator Arm, participants will receive a Placebo administered intravenous infusion every 2 weeks for a total of 7 doses.

Conditions

This trial is treating patients with acute graft versus host disease

Cancer

Blood Cancers Haematological

Age

People12+

Phase

III

Trial Acronym

EQUATOR

More information

Trial Identifiers

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Trial sponsor

Equillium

Scientific Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

Eligibility

Inclusion

  1. Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
  2. Is age ≥12 years and >40kg at informed consent/assent.
  3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
  4. Has evidence of myeloid engraftment
  5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
  6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.

Exclusion

  1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
  2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
  3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
  4. Evidence of cGVHD or overlap syndrome
  5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
  6. Use of any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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