What side effects are associated with this type of intervention?

Common treatments for B-Cell Non-Hodgkin Lymphoma, including chemotherapy, targeted therapy, and immunotherapy, often result in side effects such as neutropenia, thrombocytopenia, anemia, fatigue, nausea, vomiting, diarrhea, rash, and increased risk of infections. Treatments similar to Capivasertib, an AKT inhibitor, may also cause hyperglycemia, gastrointestinal disturbances, and skin rashes.

What prior FDA approvals exist?

Several FDA-approved treatments for B-Cell Non-Hodgkin Lymphoma include rituximab, a monoclonal antibody targeting CD20, and ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor. Additionally, idelalisib and duvelisib, which are PI3K inhibitors, target pathways related to AKT signaling. These treatments share a focus on disrupting key signaling pathways in B-cell malignancies, similar to the investigational AKT inhibitor Capivasertib.

What other types of research exist?

Promising novel alternatives to Capivasertib for B-Cell Non-Hodgkin Lymphoma patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 on B-cells and engage T-cells to kill the cancer cells. 3) Other kinase inhibitors such as ibrutinib (BTK inhibitor) and venetoclax (BCL-2 inhibitor), which have demonstrated effectiveness in various subtypes of NHL. 4) Immune checkpoint inhibitors like pembrolizumab and nivolumab, which have been explored in combination with other therapies for enhanced efficacy.

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AKT Inhibitor

Capivasertib for Non-Hodgkin's Lymphoma (CAPITAL Trial)

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status ≤ 2

Participants must be ≥ 18 years of age, at the time of signing the informed consent

Must not have

Inadequate bone marrow reserve or organ function as demonstrated by specific laboratory values

Known transformation to aggressive lymphoma for Module 1 specific exclusion criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose until data cut-off date (21.6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral medication called capivasertib in patients with certain types of B-cell Non-Hodgkin's Lymphoma who have not responded to other treatments. The goal is to see if this drug can safely and effectively treat their cancer by stopping the growth of cancer cells.

Who is the study for?

Adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment can join. They should have had at least two prior treatments, be in fairly good health (ECOG ≤ 2), and not pregnant or breastfeeding. People with certain other cancers, serious unresolved side effects from past treatments, brain involvement of lymphoma, poor bone marrow/organ function, uncontrolled diabetes needing insulin, or recent use of certain drugs are excluded.

What is being tested?

The trial is testing Capivasertib given orally to see how well it works for people whose B-cell Non-Hodgkin's Lymphoma has relapsed or is refractory. It's a Phase II study which means they're looking at the effectiveness and safety of this drug across multiple centers where everyone gets the same treatment.

What are the potential side effects?

While specific side effects for Capivasertib aren't listed here, similar cancer drugs often cause fatigue, nausea, diarrhea, low blood cell counts increasing infection risk and bleeding problems. There may also be liver issues and rash among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My diagnosis is Marginal Zone Lymphoma.

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My condition worsened after 2 treatments.

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My lymphoma is confirmed as Follicular Lymphoma Grade 1, 2, or 3a.

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I have previously received BTK inhibitor and Anti-CD20mAb therapy.

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My diagnosis of mantle cell lymphoma has been confirmed through tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood tests show my bone marrow or organs are not working well.

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My lymphoma has become more aggressive.

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I am at risk of blood clots but refuse preventive treatment.

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My condition is not follicular lymphoma grade 3B.

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I have lymphoma or disease in my brain or spinal cord.

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I have no lasting side effects from previous treatments that are moderate or worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose until data cut-off date (21.6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose until data cut-off date (21.6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose until data cut-off date (21.6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

Duration of Response

Number of Patients With Adverse Events and Serious Adverse Events

Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Capivasertib monotherapyExperimental Treatment1 Intervention

Participants with R/R FL, R/R MZL, and R/R MCL will receive capivasertib orally until progression of disease (PD) or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capivasertib

2021

Completed Phase 1

~130

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for B-Cell Non-Hodgkin Lymphoma (NHL) include targeted therapies that focus on specific molecular pathways involved in cancer cell growth and survival. Capivasertib, an AKT inhibitor, works by blocking the AKT signaling pathway, which is crucial for cell proliferation and survival. By inhibiting this pathway, Capivasertib can reduce tumor growth and induce cancer cell death. This is particularly important for B-Cell NHL patients as it offers a more precise treatment option that targets the cancer cells while potentially minimizing damage to normal cells, leading to better outcomes and fewer side effects compared to traditional chemotherapy.