Pirtobrutinib for Chronic Lymphocytic Leukemia (CLL)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
The First Affiliated Hospital of Nanchang University, Nanchang, China
Chronic Lymphocytic Leukemia (CLL)+5 More
Pirtobrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called pirtobrutinib is more effective than a drug called BR in treating people with chronic lymphocytic leukemia.

See full description

Eligible Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Pirtobrutinib will improve 1 primary outcome and 7 secondary outcomes in patients with Chronic Lymphocytic Leukemia (CLL). Measurement will happen over the course of Up to approximately 5 years.

Year 5
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Arm B (BR)
1 of 2
Arm A (Pirtobrutinib)
1 of 2
Active Control
Experimental Treatment

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pirtobrutinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm A (Pirtobrutinib)
Drug
Pirtobrutinib administered orally
Arm B (BR)Bendamustine plus rituximab administered intravenously (IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2022
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 5 years for reporting.

Closest Location

Ascension St. John Hospital - Grosse Pointe Woods, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
and estimated GFR ≥60 milliliters per minute (mL/min) on the basis of the Schwartz formula show original
The person has been confirmed to have CLL/SLL, a type of leukemia, and will need treatment. show original
An individual with ECOG Performance Status 0-2 is considered to have a good performance status and is able to carry out normal activities. show original
Adequate organ function
constitute eligibility for rituximab therapy Rituximab therapy may be considered for patients with platelets ≥75 x 10⁹/L, hemoglobin ≥8 g/dL, and absolute neutrophil count ≥0.75 x 10⁹/L. show original

Patient Q&A Section

How serious can lymphoma be?

"Results from a recent clinical trial showed that about 35% of patients who presented to the hospital with lymphoma died within 3 years after diagnosis. This is higher than expected because of the severity of lymphoma. In particular, follicular lymphoma had the highest mortality rate. More than half of deaths associated with lymphoma were caused by complications related to the disease. Results from a recent clinical trial suggest that lymphoma is an important cause of morbidity and mortality in hospitalized patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pirtobrutinib for therapeutic use?

"PBT shows promise as a promising new drug for treating HL, especially in combination with rituximab, and is being considered by multiple investigators as a potentially effective strategy for treating patients with relapsed or refractory HL. Clinical trials examining these combinations and/or in combination with other agents (e.g., belinostat), and studies investigating the impact of these therapies on progression free survival and overall survival are ongoing." - Anonymous Online Contributor

Unverified Answer

What is pirtobrutinib?

"PBT is effective in reducing disease activity and prolonging PFS in patients with relapsed/refractory rituximab-responsive indolent non-Hodgkin lymphoma harboring biallelic mutations in either the ABCG2 or BCR gene. PBT is well tolerated, with most adverse events being mild or moderate. Most patients will require ongoing immunosuppression. ClinicalTrials.gov identifier: NCT01931042." - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"Though there are no cures for lymphomas, there is research underway to find treatments which may improve survival. In particular, TNF alpha inhibitors such as infliximab are being tested against rituximab in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Further studies are needed to determine whether these agents work in patients with primary mediastinal B-cell lymphomas." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma?

"The overall 5-year survival rate for all types of lymphoma was 89.9%, 94% with MALT, 93.8% with T-cell lymphoma, 87.8% with follicular lymphoma and 86.7% with small lymphocytic lymphoma. In addition, these rates were 91.4% with B-cell lymphoma, 88.6% with Hodgkin’s disease, 82.5% with diffuse large B-cell lymphoma, 81.6% with Burkitt’s lymphoma and 80% with chronic lymphocytic leukemia. These are comparable to those reported elsewhere. It seems reasonable to assume that survival in lymphoma has improved over the last 40 years." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"Based on the results presented here, it appears that if we provide an accurate definition of lymphoma then people will be more likely to recognize and know about lymphoma. If we are able to correctly identify lymphoma, people will be better able to understand the importance of early detection and treatment." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma?

"It is suggested that a lymphoma screening programme should be established for at risk populations, including those living overseas who are not compliant with routine immunisation programmes." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pirtobrutinib?

"PBTNIB demonstrated promising activity in both relapsed or refractory CLL/SLL and MM. However, preliminary data suggest that pirtobrutinib appears to have fewer adverse events and comparable safety profile compared with other IMiDs." - Anonymous Online Contributor

Unverified Answer

Does lymphoma run in families?

"Recent findings indicate that familial clustering of lymphoma is real in some but not all families. Further research needs to be done to determine if familial clustering is related to genetic or environmental factors." - Anonymous Online Contributor

Unverified Answer

Is pirtobrutinib typically used in combination with any other treatments?

"PBT is typically used in combination with other treatments. In contrast to other BTs, which have been found to be effective in single-agent regimens, pBT can be considered a standard 2-drug regimen." - Anonymous Online Contributor

Unverified Answer

Does pirtobrutinib improve quality of life for those with lymphoma?

"PBT may be associated with improvements in HRQoL among patients with primary or secondary lymphoma compared to mTOR inhibitors alone. Results from a recent paper warrant further investigation of PBT as a first line therapy for this patient population." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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