Informations générales (source: ClinicalTrials.gov)

NCT05665530 En recrutement IDF
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With Relapsed/Refractory Hematologic Malignancies
Interventional
  • Agressivité
  • Leucémies
  • Leucémie lymphoïde
  • Leucémie myéloïde
  • Lymphomes
  • Lymphome malin non hodgkinien
  • Syndromes myélodysplasiques
  • Syndromes myéloprolifératifs
  • Tumeurs
  • Préleucémie
  • Syndrome
  • Leucémie chronique lymphocytaire à cellules B
  • Leucémie aigüe myéloïde
  • Leucémie myélomonocytaire chronique
  • Lymphome B
  • Lymphome T
  • Lymphome B diffus à grandes cellules
  • Lymphome T périphérique
  • Lymphome B de la zone marginale
  • Tumeurs hématologiques
  • Lymphome à cellules du manteau
  • Leucémie myélomonocytaire juvénile
Phase 1
Prelude Therapeutics (Voir sur ClinicalTrials)
septembre 2023
mars 2026
23 août 2024
This is a Phase 1 dose-escalation study of PRT2527, a potent and highly selective cyclin-dependent kinase (CDK) 9 inhibitor, in participants with select relapsed or refractory (R/R) hematologic malignancies. The purpose of this study is to evaluate the safety, tolerability, recommended phase 2 dose (PR2D), and preliminary efficacy of PRT2527 as a monotherapy and in combination with zanubrutinib or venetoclax.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC RENE HUGUENIN INSTITUT CURIE En recrutement IDF 04/09/2024 13:49:26 Contact (sur clinicalTrials)
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Henri Mondor-Albert Chenevier En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Léon Bérard - 69373 Cedex 08 - Lyon - France En recrutement Contact (sur clinicalTrials)
Claude Huriez Hospital - 59000 - Lille - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, lifestyle considerations, and other study procedures

- Histologically or cytologically confirmed diagnosis of aggressive B-cell lymphoma
subtypes, MCL, MZL, or CLL/SLL (including Richter's syndrome) based on local
testing, or TCL (monotherapy only), AML, CMML, MDS, or MDS/MPN overlap syndrome that
have relapsed or become refractory to or be ineligible for standard-of-care therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2.

- Adequate organ function (hematology, renal, and hepatic)

- Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular
ejection fraction of ≥ 50%


- Have active central nervous system involvement by malignancy, uncontrolled
intercurrent illnesses, and active infections requiring systemic therapy

- Have undergone HSCT within the last 90 days or have graft versus host disease (GvHD)
Grade > 1 at study entry

- Have severe pulmonary disease with hypoxemia

- History of another malignancy except for adequately treated non-melanoma skin cancer
or lentigo maligna, superficial bladder cancer, and carcinoma in situ of the cervix
without evidence of disease, and asymptomatic prostate cancer without known
metastatic disease and no requirement for therapy

- Concurrent treatment or within 15 days of starting study treatment with strong
CYP3A4 inhibitors

- Prior exposure to a CDK9 inhibitor

- Wait at least 5 half-lives of the agent or 14 days after their investigational or
approved therapies before start of study treatment, whichever is shorter

- Mean corrected QT interval of > 470 msec following triplicate ECG measurement or
history of long QT syndrome

- T-Cell leukemias