Acalabrutinib for Leukemia, Lymphoid

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Utrecht, Netherlands
Leukemia, Lymphoid+3 More
Acalabrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat chronic lymphocytic leukemia.

See full description

Eligible Conditions

  • Leukemia, Lymphoid
  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Leukemia, Lymphoid

Study Objectives

This trial is evaluating whether Acalabrutinib will improve 1 primary outcome, 3 secondary outcomes, and 5 other outcomes in patients with Leukemia, Lymphoid. Measurement will happen over the course of From the start of study treatment to safety follow-up period (approximately 30 days from last dose).

Year 1
Objective response rate (ORR)
Day 1
Plasma concentrations of acalabrutinib and ACP 5862
Day 30
Number of participants with adverse events
Day 30
Time to next treatment
Day 28
Progression-free survival (PFS)
Day 28
Duration of response (DOR)
Year 1
Overall survival (OS)
Day 28
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Leukemia, Lymphoid

Side Effects for

Acalabrutinib + BSC
Headache
12%
Pneumonia
2%
Respiratory failure
2%
Bacterial sepsis
1%
Mucosal infection
1%
Acute kidney injury
1%
Pleural effusion
1%
Hypotension
1%
Septic shock
0%
Chronic obstructive pulmonary disease
0%
Ischaemic stroke
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04346199) in the Acalabrutinib + BSC ARM group. Side effects include: Headache with 12%, Pneumonia with 2%, Respiratory failure with 2%, Bacterial sepsis with 1%, Mucosal infection with 1%.

Trial Design

1 Treatment Group

Acalabrutinib
1 of 1
Experimental Treatment

This trial requires 553 total participants across 1 different treatment group

This trial involves a single treatment. 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 3 and have had some early promising results.

Acalabrutinib
Drug
Participants will be enrolled into 3 cohorts. In the treatment-naive (TN) cohort, a minimum of 300 participants with treatment-naïve chronic lymphocytic leukemia will be enrolled. In the relapsed/refractory (R/R) cohort, approximately 200 participants with relapsed/refractory chronic lymphocytic leukemia will be enrolled. In the prior Bruton tyrosine kinase inhibitor (BTKi) therapy cohort, up to 70 to 100 participants with Prior BTKi therapy will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year after initial dose of study drug
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year after initial dose of study drug for reporting.

Closest Location

Research Site - Hartford, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia, Lymphoid or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, and ≥10% of lymph nodes with unequivocal Hodgkin's lymphoma on morphologic examination are required for the diagnosis of classical Hodgkin's lymphoma show original
In patients with progressive lymphocytosis, if the increase is greater than 50% over a 2-month period or the lymphocyte doubling time is less than 6 months, then the patient may have chronic lymphocytic leukemia show original
The text is about symptoms of Splenomegaly show original
are considered to be abnormal Monoclonal B-cells that are clonally co-expressing ≥1 B-cell marker (CD19, CD20, and CD23) and CD5 are considered to be abnormal. show original
and a sustained decrease in their number to <5 × 109 cells/L (5000/μL) on 2 or more consecutive occasions at least 6 weeks apart show original
People aged 18 or over are able to consent to taking part in this study. show original
Lymphocytes can be divided into two main types: prolymphocytes and mature lymphocytes show original
Active disease as per at least 1 of the following IWCLL 2018 criteria
The development of anemia and/or thrombocytopenia may be indicative of progressive marrow failure. show original
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy

Patient Q&A Section

What causes leukemia?

"Leukemia develops from genetic mutations in early blood cells as well as exposure to environmental toxins, with the two categories of exposures being the most powerful factors. The most likely cause for any type of leukemia is a combination of these two forces. Genetic mutations can take place at any time during development and may result in different types of leukemia. The mechanism of leukemogenesis is complex and still poorly understood." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"This list is representative of many forms of cancer and its treatments. Although some cancer is curable at diagnosis, most forms of cancer, whether cancer of the bone, breast, brain, brainstem, liver, ovarian, colon, pancreas, prostate, or testis, have no cure." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"The most important signs of cancer are the symptoms, which include the usual pain and mass, itching, bleeding, and skin rashes. Cancer must come to your attention before these signs have set in and the disease can no longer be treated. If there are no symptoms, a dentist could be the first person you turn to as you try to find the first sign" - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"Leukemogenesis is the process in which a normal, healthy person is transformed into a cancerous one by mutation or environmental exposure to a carcinogen. Leukaemias and other cancers are all associated with the presence of a mutation in one of the cancer-causing genes. The majority of leukaemias and lymphomas occur on the bone marrow." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"It is difficult to cure a leukemia (in particular AML due to its high level of resistance to conventional chemotherapy). However, with improved knowledge, strategies have been developed that are potentially effective in AML." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia a year in the United States?

"The current US estimates may be as low as 7,926/year. If the current estimates are accurate, this might require a screening program to detect disease at an early stage." - Anonymous Online Contributor

Unverified Answer

What is acalabrutinib?

"Ibrutinib is FDA approved for use in mantle cell lymphoma (since 2013) and (after FDA approval in 2017) a rare form of chronic lymphocytic leukemia also called mantle cell lymphoma." - Anonymous Online Contributor

Unverified Answer

How serious can leukemia be?

"Most pediatric patients are in good or very good spirits after treatment (chemo therapy) due to their good prognosis. But most parents, who are usually not able to come to see their child because of their busy work, go through an awful ordeal: the fear of their child's prognosis, the stress and the hope of getting cured but not dying from leukemia. This is what people need to understand to avoid bad attitudes towards doctors, patients and the whole medical field of treatment and cure." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia?

"Most people have a family history of leukemia or certain genetic traits. But even when these genetic risk factors are present, there are many people without leukemia. Therefore, the question of whether or not someone has leukemia is best phrased as 'how likely is this person to develop leukemia?" - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia?

"Approximately 59% of leukemia cases diagnosed in the country of Spain are reported in patients aged 50 years or older. This may reflect the increased number and severity of hematological malignancies in this population, which requires early diagnostic interventions (e.g., screening programs, improved treatment regimens, and earlier detection of these disorders)." - Anonymous Online Contributor

Unverified Answer

Does acalabrutinib improve quality of life for those with leukemia?

"In patients with solid tumors, treatment-related pain is commonly reported as an adverse event. The use of acalabrutinib is associated with significant improvement in pain, and may be a reasonable adjunct for patients with pain from solid tumors. This trial was registered at clinicaltrials.gov as NCT01319307." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating leukemia?

"Results from a recent clinical trial of chemotherapeutic and immuno-therapeutic agents for treating patients with Acute Myeloid Leukemias (AML) and Chronic Myeloid Leukemias (CML) over this period is not as much as expected especially with the advances in treatment techniques especially using the new drugs and the drug combinations. Oncologists should be aware of the advances in treatments in CML and AML especially when looking forward for future development of drugs that is specific to either the diseases." - 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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