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Taking people in ItalyPhase 1/2

Tests KRT-232 with acalabrutinib in adults with returned lymphoma or leukemia

Tests KRT-232 with acalabrutinib in adults whose lymphoma or leukemia has returned.

Key facts

Who runs it
Kartos Therapeutics, Inc.
Where
Aviano, Meldola, Milan, Pavia, and Verona, ItalySee the 6 sitesAlso in 10 other countries, 39 sites
Trial code
Registry title
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
Status
Recruiting
Phase
Phase 1/2
People taking part
84 people, planned
Started
23 Feb 2021
Planned end
Mar 2024
Type of study
Interventional, 2 groups
Treatments tested
  • KRT-232
  • acalabrutinib
Record updated
4 August 2022

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose diffuse large B-cell lymphoma (DLBCL) or chronic lymphocytic leukemia (CLL) came back or did not respond to earlier treatment. The tumor must have a normal (wild-type) TP53 gene.

Age
18 years or older
Sex
All sexes can join
Disease stage
Cohort 1: DLBCL that came back or did not respond after at least 2 earlier lines of treatment, or 1 earlier line if a stem cell transplant is not possible. Cohort 2: CLL that came back or did not respond after at least 1 earlier line of treatment. ECOG 0 to 2.
Earlier treatment
Cohort 1: at least 2 earlier lines of treatment, or 1 if a stem cell transplant is not possible. Cohort 2: at least 1 earlier line of treatment. No earlier MDM2 inhibitor or BTK inhibitor.
Biomarker or test result
TP53wt (normal, wild-type TP53 gene) DLBCL or CLL

Main reasons for not taking part

  • Earlier treatment with any MDM2 inhibitor
  • Earlier treatment with any BTK inhibitor

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant
  • Cohort 2: Confirmed diagnosis of TP53wt CLL (iwCLL); R/R CLL after at least 1 prior line of treatment
  • ECOG 0 to 2
  • Adequate hematologic, hepatic, and renal functions

Who cannot take part

  • Prior treatment with any MDM2 inhibitor
  • Prior treatment with any BTK inhibitor

Where in Italy

Also in 10 other countries, 39 sites

  • Centro Riferimento Oncologico - AvianoAviano, ItalyContact: John MeiTaking people
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriMeldola, ItalyContact: John MeiTaking people
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: John MeiTaking people
  • IRCCS Ospedale San RaffaeleMilan, ItalyContact: John MeiTaking people
  • Fondazione IRCCS Policlinico San MatteoPavia, ItalyContact: John MeiTaking people
  • Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyContact: John MeiTaking people

About the trial

What the trial wants to find out

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

The 2 groups in the trial

  • Cohort 1 (R/R DLBCL)Treatment being tested

    KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle. Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.

    Treatment: KRT-232 and acalabrutinib

  • Cohort 2 (R/R CLL)Treatment being tested

    KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle. Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.

    Treatment: KRT-232 and acalabrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia
Plain-language title
Tests KRT-232 with acalabrutinib in adults with returned lymphoma or leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 August 2022