CLINICAL TRIAL

Acalabrutinib for Lymphoma, Mantle-Cell

Grade I
Metastatic
Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether acalabrutinib may be effective in treating mantle cell lymphoma.

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About the trial for Lymphoma, Mantle-Cell

Eligible Conditions
Mantle Cell Lymphoma (MCL) · Lymphoma · Lymphoma, Mantle-Cell

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
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

Side Effect Profile for BSC Alone

BSC Alone
Show all side effects
2%
Headache
1%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
0%
Respiratory failure
0%
Acute kidney injury
0%
Pleural effusion
0%
Pneumonia
0%
Hypotension
0%
Bacterial sepsis
0%
Mucosal infection
Headache
2%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
1%
Respiratory failure
0%
Acute kidney injury
0%
Pleural effusion
0%
Pneumonia
0%
Hypotension
0%
Bacterial sepsis
0%
Mucosal infection
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04346199) in the BSC Alone ARM group. Side effects include: Headache with 2%, Septic shock with 1%, Ischaemic stroke with 1%, Chronic obstructive pulmonary disease with 1%, Respiratory failure with 0%.

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:
of disease was associated with a significantly longer time to progression and overall survival People who had to stop taking ibrutinib for any reason other than their disease progressing had a longer time until their disease progressed and a longer overall survival time. show original
1 or more grade 4 neutropenia The patient must have experienced 2 or more grade >= 2 non-hematological toxicities; OR 1 or more grade 3 >= 3 non-hematological toxicity; OR 1 or more grade 3 neutropenia with infection or fever; OR 1 or more grade 4 neutropenia. show original
Grade 4 hematologic toxicity which persists to the point that the investigator chose to stop therapy due to an inability to manage the toxicity. show original
The patient's toxicity must have resolved to grade 1 or lower prior to starting acalabrutinib therapy. show original
The Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less means that the person is able to carry out light work or complete simple tasks. show original
A count of more than 1,000 neutrophils per cubic millimeter is considered to be high. show original
Confirmed diagnosis of mantle cell lymphoma with CD20 positivity and chromosome translocation t(11;14), (q13;q32) and/or overexpress cyclin D1 in tissue biopsy
People who need treatment will be treated, while those who don't need treatment will be watched/waited on. show original
The person understands the purpose of the study and agrees to take part in the study by voluntarily signing an IRB-approved informed consent form. show original
Bi-dimensional measurable disease using the Cheson criteria (measurable disease by positron emission tomography [PET]-computed tomography [CT] scan defined as at least 1 lesion that measures >= 1.5 cm in single dimension). Gastrointestinal, bone marrow or spleen only patients are allowable
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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 6 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 6 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 6 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 and 3 secondary outcomes in patients with Lymphoma, Mantle-Cell. Measurement will happen over the course of At the end of cycle 3 (each cycle is 28 days).

Overall response rate (complete response + partial response)
AT THE END OF CYCLE 3 (EACH CYCLE IS 28 DAYS)
The primary end point will be met if > 50% patients attain response (half of patients responding without intolerance). Logistic regression may be utilized to assess the effect of patient prognostic factors on the response rate. Intent-to-treat analysis will be applied to the eligible patients.
AT THE END OF CYCLE 3 (EACH CYCLE IS 28 DAYS)
Incidence of adverse events
AT THE END OF CYCLE 3 (EACH CYCLE IS 28 DAYS)
Logistic regression may be utilized to assess the effect of patient prognostic factors on the incidence of adverse events. Toxicity and safety data will be summarized by frequency tables for all patients and then will be reviewed for relatedness to acalabrutinib. Per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. Also, time to event and time to event resolution will be calculated.
AT THE END OF CYCLE 3 (EACH CYCLE IS 28 DAYS)
Overall survival
UP TO 6 YEARS
The distribution of time-to-event endpoints including overall survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
UP TO 6 YEARS
Progression free survival
UP TO 6 YEARS
The distribution of time-to-event endpoints including progression free survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
UP TO 6 YEARS

Patient Q & A Section

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

Does acalabrutinib improve quality of life for those with lymphoma, mantle-cell?

AC is safe and well tolerated, with improvement in lymphoma-related symptoms, including pain, itch, or swelling. In patients with lymphoma-related symptoms and fatigue, those using AC were even more likely to experience improvement in these symptoms during 12 weeks of treatment.

Anonymous Patient Answer

Is acalabrutinib safe for people?

Acalabrutinib had an overall safety profile comparable to that seen in people with mantle cell lymphoma. However, more studies are needed to further assess the safety of this agent.

Anonymous Patient Answer

Who should consider clinical trials for lymphoma, mantle-cell?

Younger adults with newly diagnosed lymphoma are commonly admitted and treated at a tertiary centre. A greater involvement of the local rheumatology and oncology services will be needed in the future.

Anonymous Patient Answer

What causes lymphoma, mantle-cell?

This disease process is multifactorial with genetic, environmental and heredity-related factors. Exposure to pesticides and agricultural chemicals, particularly dioxins, may contribute to neoplastic development and to the progression and persistence of disease.

Anonymous Patient Answer

What are common treatments for lymphoma, mantle-cell?

Only two thirds of CLL patients in this study received standard chemotherapy, indicating a need for more research into effective treatment. The findings indicate that patients with CLL should be enrolled in clinical trials even if they cannot be enrolled in standard trials if novel therapies are used.

Anonymous Patient Answer

What is lymphoma, mantle-cell?

In adults, mantle-cell lymphoma is the most common type of Non-Hodgkin's lymphoma in the United Kingdom. It has a poor prognosis and is often associated with autoimmune disorders. The risk of secondary mantle-cell lymphoma is much reduced with treatment of these disorders. We present a case of mantle-cell lymphoma in a HIV-positive, Caucasian male.

Anonymous Patient Answer

Can lymphoma, mantle-cell be cured?

Results from a recent clinical trial of this study do not indicate that the clinical or in vitro-induced apoptosis of lymphoma cells can be significantly improved through the combined treatment of a few drugs for more than 12 months, although a large percentage of patients have clinical complete remission. The long-term clinical remission is not always related to in vitro-induced apoptosis.

Anonymous Patient Answer

How many people get lymphoma, mantle-cell a year in the United States?

About 11,990 people were diagnosed with MCL in 2015. These data support our previous retrospective assessment which shows that this disease is the third most common form of NHL in patients who present with lymphadenopathy and/or splenomegaly.

Anonymous Patient Answer

What are the signs of lymphoma, mantle-cell?

Some of the signs of lymphoma, mantle-cell are: frequent, prolonged sore throats, low back pain, swollen lymph nodes, fever, pale eyes, weight loss and decreased appetite. Most of these signs are similar to signs of another cancer, such as stomach or bowel cancer. The only clue that might point you towards lymphoma is an unusual blood test, such as a low lymphocyte or increased monocyte count, or a marker of inflammation that indicates a problem in your immune system, such as high-sensitivity C-reactive protein or interleukin-6. Sometimes, lymphoma will mimic more serious conditions. A bone marrow biopsy is the definitive testing for lymphoma.

Anonymous Patient Answer

What are the chances of developing lymphoma, mantle-cell?

These data suggest that the majority of LTCL patients in the USA are diagnosed at or prior to the time of diagnosis of CLL/SSc, demonstrating a temporal relationship that merits further investigation. A significant percentage of CLL/SSc patients with mantle-cell lymphoma will develop lymphoma, suggesting that the diagnosis of CLL/SSc is not sufficient for achieving accurate management of these patients. Thus, patients with mantle-cell lymphoma should be managed similarly to those with CLL/SSc, even if diagnosed at an earlier stage.

Anonymous Patient Answer

What does acalabrutinib usually treat?

This case describes a patient receiving the FDA-approved drug acalabrutinib for palliative management of primary cutaneous T-cell lymphoma and secondary cutaneous T-cell lymphoma and who develops a neutropenic fever in the setting of profound lymphopenia. Based on this case, acalabrutinib should only be prescribed for patients with primary cutaneous T-cell lymphoma and secondary cutaneous T-cell lymphoma or an acceptable comorbidity level. Acalabrutinib should not be prescribed to patients whose diagnosis includes mycosis fungoides or Sézary disease.

Anonymous Patient Answer

What are the common side effects of acalabrutinib?

Common side effects of acalabrutinib treatment in combination with bortezomib include fever, dyspnoea, malaise, fatigue, nausea, headache, peripheral nerves and pain. In conclusion, acalabrutinib seems to be safe in clinical practice for patients with mantle-cell lymphoma. The common side effects are not serious, and it is recommended that they be closely monitored.

Anonymous Patient Answer
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