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Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)

NCT05008055•AstraZeneca

View on ClinicalTrials.gov

Summary

This study is an open-label, multicenter Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

Detailed Description

The study protocol follows a modular design. The study will investigate the safety and efficacy of capivasertib monotherapy in participants with R/R Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL).

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must be ≥ 18 years of age, at the time of signing the informed consent
•Eastern Cooperative Oncology Group performance status ≤ 2
•Life expectancy \> 6 months
•Female participants must not be breast-feeding and must have a negative pregnancy test (serum) prior to start of dosing
•1. Histologically confirmed diagnosis of FL Grade 1, 2, or 3a as assessed by investigator or local pathologist
•2. Current need for systemic treatment based on the Investigator's opinion
•3. Relapsed, progressed or refractory (defined as failure to achieve at least a partial response \[PR\]) after at least 2 prior systemic lines of therapy (including anti-CD20 monoclonal antibody \[mAb\] and an alkylating agent)
•4. Bi-dimensionally measurable disease on cross sectional imaging by computed tomography (CT) or magnetic resonance imaging (MRI) with at least one nodal lesion \> 1.5 cm in the long axis or at least one extranodal lesion \> 1 cm in long axis.
•1. Histologically confirmed MZL including splenic, nodal, and extranodal subtypes as assessed by investigator or local pathologist
•2. Current need for systemic treatment based on the Investigator's opinion
+9 more criteria

Exclusion Criteria

•Prior malignancy (other than the disease under study), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the participant has been disease free for ≥ 2 years
•With the exception of alopecia, any unresolved non-haematological toxicities from prior therapy ≥ Common Terminology Criteria for Adverse Events Grade 2 at the time of starting study treatment
•Known medically apparent central nervous system lymphoma or leptomeningeal disease
•Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values at screening:
•1. Absolute neutrophil count \< 1.0 × 10\^9/L; \< 0.75 × 10\^9/L in participants with known bone marrow involvement of malignant disease
•2. Platelets \< 75 × 10\^9/L; \< 50 × 10\^9/L in participants with known bone marrow involvement of malignant disease
•3. Creatinine clearance \< 50 mL/min per the Cockcroft and Gault formula
•Clinically significant abnormalities of glucose metabolism as participants with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment and Glycosylated haemoglobin ≥ 8.0% (63.9 mmol/mol)
•Prior treatment with any of the following:
•1. Any investigational agents or study drugs from a previous clinical study within 5 half lives or 2 weeks from the first dose of capivasertib in this study
+8 more criteria

Locations (17)

Research Site

Duarte, California, United States

Research Site

Los Angeles, California, United States

Research Site

Houston, Texas, United States

Research Site

Victoria, British Columbia, Canada

Research Site

Aarhus N, Denmark

Research Site

Poitiers, France

Research Site

Villejuif, France

Research Site

Busan, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Key Dates

Start Date

November 3, 2021

Primary Completion Date

August 22, 2023

Completion Date

October 25, 2024

Last Updated

December 20, 2024

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Interventions

Capivasertib

DRUG

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

UNKNOWNPHASE1/PHASE2

Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes

NCT02134262

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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: December 20, 2024Data 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.

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