CLINICAL TRIAL

Acalabrutinib for Lymphoma, Follicular

Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether a combination of drugs may help treat patients with follicular lymphoma.

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About the trial for Lymphoma, Follicular

Eligible Conditions
Ann Arbor Stage III Grade 2 Follicular Lymphoma · Ann Arbor Stage III Grade 1 Follicular Lymphoma · Ann Arbor Stage IV Grade 1 Follicular Lymphoma · Lymphoma, Follicular · Lymphoma · Ann Arbor Stage III Grade 3 Follicular Lymphoma · Ann Arbor Stage IV Grade 3 Follicular Lymphoma · Ann Arbor Stage IV Grade 2 Follicular Lymphoma · Grade 3a Follicular Lymphoma

Treatment Groups

This trial involves 2 different treatments. Acalabrutinib 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 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Acalabrutinib
DRUG
Lenalidomide
DRUG
Rituximab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tyrosine
FDA approved
Lenalidomide
FDA approved
Rituximab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person has never received any treatment for lymphoma before. show original
Stage III or IV disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Acalabrutinib will improve 1 primary outcome, 7 secondary outcomes, and 2 other outcomes in patients with Lymphoma, Follicular. Measurement will happen over the course of From the date of cycle 1, day 1 to the date of first documented progression, transformation to diffuse large B-cell lymphoma, initiation of new anti-lymphoma treatment, or death, assessed up to 3 years.

Progression-free survival
FROM THE DATE OF CYCLE 1, DAY 1 TO THE DATE OF FIRST DOCUMENTED PROGRESSION, TRANSFORMATION TO DIFFUSE LARGE B-CELL LYMPHOMA, INITIATION OF NEW ANTI-LYMPHOMA TREATMENT, OR DEATH, ASSESSED UP TO 3 YEARS
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% confidence interval. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on progression-free survival.
Overall survival
FROM THE DATE OF CYCLE 1, DAY 1 TO THE DATE OF DEATH REGARDLESS OF CAUSE, ASSESSED UP TO 3 YEARS
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% confidence interval. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on overall survival.
Progression-free survival within 24 months from treatment initiation
FROM THE TREATMENT START DATE (CYCLE 1, DAY 1) UNTIL THE FIRSTDATE OF OBJECTIVELY DOCUMENTED PROGRESSIVE DISEASE OR DATE OF DEATH FROM ANY CAUSE, ASSESSED UP TO 24 MONTHS
Will be estimated by the Kaplan-Meier method. Corresponding 95% confidence intervals will be summarized. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on progression-free survival.
Overall response rate (complete response + partial response)
(AT THE END OF TREATMENT ; 1 YEAR )
Will be based on Cheson, Lugano classification 2014. The number and percentage of subjects with an overall response rate will be tabulated. The best overall response rate will be recorded.
Complete remission rate
(UP TO END OF TREATMENT; 1 YEAR)
Will be based on Cheson, Lugano classification 2014. The number and percentage of subjects with a complete remission at the end of treatment will be tabulated.
Duration of response
FROM THE TIME BY WHICH MEASUREMENT CRITERIA FOR COMPLETE RESPONSE OR PARTIAL RESPONSE, WHICHEVER IS RECORDED FIRST, IS MET UNTIL DEATH OR THE FIRST DATE BY WHICH PROGRESSIVE DISEASE IS DOCUMENTED, ASSESSED UP TO 3 YEARS
Will be based on Cheson, Lugano classification 2014. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on duration of response. Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% confidence interval.
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Patient Q & A Section

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

Has acalabrutinib proven to be more effective than a placebo?

Compared with placebo, acalabrutinib demonstrated substantial activity in patients with NHL and myelodysplastic syndromes (MDS) with a low risk of hemorrhage or thrombocytopenia, with and without bortezomib (Velcade) induction.

Anonymous Patient Answer

What are the common side effects of acalabrutinib?

The common adverse effects of acalabrutinib are similar to the common adverse effects of ibrutinib and nilotinib. Some of the most common adverse effects for ibrutinib and nilotinib are similar, including diarrhoea, fever, and fatigue. Serious adverse effects are rare. One of the most common side effects in this population is progressive multifocal leukoencephalopathy, but this occurs infrequently with ibrutinib and nilotinib and may be related to the use of interferon alpha-2a, a common drug at initiation of therapy.

Anonymous Patient Answer

How many people get lymphoma, follicular a year in the United States?

The incidence of NLPHL has increased significantly in the past decade whereas the incidence of other types of NHL have decreased. The age-adjusted incidence of NLPHL has remained consistent throughout the survey period while the age-adjusted incidence for B-PLL and PCL has significantly increased.

Anonymous Patient Answer

What is lymphoma, follicular?

Lymphoma, follicular is a cancer of the lymph tissue. Lymphoma follicular usually arises in the elderly and usually affects both the male and female sex.\n

Anonymous Patient Answer

What are common treatments for lymphoma, follicular?

Lymphoma is one of the most disabling cancers. Most cases are treatable, although patients may need some form of post-treatment rehabilitation and ongoing supervision. Treatment is highly varied, and depends mainly on the particular type of lymphoma.

Anonymous Patient Answer

What are the signs of lymphoma, follicular?

Signs of lymphoma, follicular are nonspecific and may include enlarged or tender enlarged lymph nodes, fever, enlargement of lymph nodes (glandular or non-glandular), a good general health, and weight loss. They may also represent other disorders, and are not diagnostic of lymphoma or follicular lymphoma. Lymphoma, follicular has an incidence of approximately 1:40,000 to 1 per year, and is most commonly found in non-Hodgkin lymphoma. The most common age of occurrence is 40 years or older. Its pathogenesis is unknown. The most common cause of lymphoma, follicular is a low grade lymphoma that mimics other lymphoma.

Anonymous Patient Answer

What causes lymphoma, follicular?

Lymphoma, follicular affects younger women more often than older women and has the same prognosis. This disease's effects on the [immune system and immune mechanism] may be due to how lymphoma cells may alter the [host lymphocyte responses] and to the [immune system's effects on the] immune tolerance in the cancer patients' bodies. For interested people on lymphoma clinical trials, please visit [Power (http://www.withpower.com/d/lymphoma-follicular-clinical-trials).

Anonymous Patient Answer

Can lymphoma, follicular be cured?

Data from a recent study has identified that a high percentage of non-cured lymphomas may be cured by cytotoxic chemotherapy using a modified BEP regimen.

Anonymous Patient Answer

What is acalabrutinib?

After the initiation of the first 3-trexaflavone and/or acalabrutinib regimen, responses to therapy were durable in both PBC and CHB, and were generally comparable in both PBC and CHB. Importantly, our data suggest that combined therapy with acalabrutinib may help to prevent relapse of the initial relapse in patients with PBC.

Anonymous Patient Answer

What does acalabrutinib usually treat?

Acalabrutinib treats a specific type of T-cell lymphoma that can be difficult to treat with other types of T-cell lymphomas, and it is approved for that indication. It also treats the skin rash associated with relapsed/refractory T-cell lymphoma, and some patients benefit from treatment with the drug. However, acalabrutinib is not approved to treat cutaneous T-cell lymphoma as a monotherapy. The most common side effects with acalabrutinib are muscle aches, headache, and nausea; these side effects were common to both treatment groups and they were well controlled with medication.

Anonymous Patient Answer

What is the survival rate for lymphoma, follicular?

There is no data available on the survival rate of [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma). However, the data from the Lymphoma Information and Coordination Center (LICC) Survival Tables (https://www.cimaging.nl/service/licc/survival-tables#) shows a [13 month ] survival rate of 60% in patients who did not receive radiotherapy, the largest percentage of all patients. In patients receiving radiotherapy, a [13 month ] survival rate of 67.5% is shown. Although there is no data available on these patients in early stages, this [13 month ] survival rate should be kept in mind when selecting a treatment.

Anonymous Patient Answer

How does acalabrutinib work?

Acalabrutinib is a drug which inhibits the phosphorylation, thereby lowering the turnover of PI3K. However, the mechanisms how to overcome this is not clear. It has been observed that in order to be a drug targeting PI3K, a large difference between the interaction of the binding partner (either PI3K or the accessory protein in the complex) and the binding site of the partner has to occur, since the protein kinase has a highly conserved amino acid region (LXV-YFV, where X should be Leu or Ile) and the only PI3K which is able to bind it is PTEN.

Anonymous Patient Answer
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