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Acalabrutinib for Mantle Cell Lymphoma

Weill Cornell Medicine, New York, NY
Mantle Cell LymphomaAcalabrutinib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new combination therapy for mantle cell lymphoma, which is a cancer of the lymph nodes. The treatment consists of 12 cycles of three drugs, after which responding patients can enter a maintenance phase. The goal is to see if the treatment is effective and safe.

Eligible Conditions
  • Mantle Cell Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide)

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 4 years

1 year
Peripheral blood minimum residual disease (MRD)-negative complete response (CR) rate of the combination of acalabrutinib + lenalidomide + rituximab at the conclusion of 12 cycles of induction therapy
4 years
Complete response rate
Overall response rate
Overall survival
Progression free survival
Safety of combination treatment with acalabrutinib, lenalidomide, and rituximab as measured by the percentage of subjects that experience 1 or more adverse event
Time to next treatment

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Acalabrutinib
1
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1
Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide)

Side Effects for

BSC Alone
2%Headache
1%Septic shock
1%Ischaemic stroke
1%Chronic obstructive pulmonary disease
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%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

ALR in Combination
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 2

ALR in CombinationExperimental Group · 3 Interventions: Lenalidomide, Acalabrutinib, Rituximab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Acalabrutinib
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
441 Previous Clinical Trials
57,918 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,057 Previous Clinical Trials
240,391,230 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,009 Previous Clinical Trials
1,346,928 Total Patients Enrolled
Jia Ruan, M.D., Ph.D.Principal InvestigatorWeill Medical College of Cornell University

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor must recommend that you receive treatment.
References

Frequently Asked Questions

Has Acalabrutinib been given the green light from the Food and Drug Administration?

"Acalabrutinib's safety is assessed as a 2 on our scale because though there are some studies that attest to its security, there are none yet confirming its effectiveness." - Anonymous Online Contributor

Unverified Answer

What symptoms does Acalabrutinib typically alleviate?

"Acalabrutinib is a commonly used pharmaceutical for treating diffuse large b-cell lymphoma (DLBCL), though it can also be effective in managing other ailments such as patients who have had at least two previous systemic chemotherapy treatments, B-Cell Lymphomas and Polyangium." - Anonymous Online Contributor

Unverified Answer

How large is the cohort participating in this research project?

"Correct. According to clinicaltrials.gov, this medical study which was originally advertised on October 11th 2019 is still actively recruiting patients. 24 participants must be recruited from a single trial site." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities for participants in this research trial?

"According to the clinicaltrials.gov data, this research trial is currently open for recruitment with a posting date of October 11th 2019 and an edit on October 17th 2022." - 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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