Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL
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|ClinicalTrials.gov Identifier: NCT04685915|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : May 19, 2022
This research study is examining the effect of adding a fixed duration of copanlisib to ibrutinib or acalabrutinib in select participants who have been on ibrutinib or acalabrutinib for at least six months for relapsed/refractory chronic lymphocytic leukemia (CLL).
The names of the study drugs involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia (CLL)||Drug: Ibrutinib Drug: Copanlisib Drug: Acalabrutinib||Phase 2|
This is an open-label, phase II study, adding copanlisib to ibrutinib or acalabrutinib in select participants who are receiving ibrutinib for relapsed/refractory CLL.
Copanlisib has not been approved by the U.S. Food and Drug Administration (FDA) for CLL, but it has been approved for use in relapsed/refractory follicular lymphoma. Ibrutinib and acalabrutinib are approved by the FDA as a treatment option for CLL.
This research study is:
- Trying to understand what effects, good or bad, treatment with copanlisib in combination with ibrutinib or acalabrutinib has in select participants who are receiving ibrutinib for relapsed/refractory CLL
- Determining if this approach is better or worse than the usual approach for this type of cancer
- Determining whether genomic changes in CLL cells and changes in immune response make treatment with the study drugs more or less effective
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive combination therapy for six months before resuming ibrutinib alone. They will continue therapy for as long as they do not have serious side effects and their disease does not get worse and will be followed for up to 5 years.
It is expected that about 30 people will take part in this research study.
Bayer HealthCare Pharmaceuticals is supporting this research study by providing the study drug, copanlisib. Ibrutinib and acalabrutinib will be obtained from commercial supply.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Copanlisib to Deepen Response in CLL Patients on Ibrutinib or Acalabrutinib in the Relapsed/Refractory Setting|
|Actual Study Start Date :||February 18, 2021|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2028|
Experimental: Ibrutinib + Copanlisib/Acalabrutinib
During 28 day study treatment cycle, participants will:
Capsule, taken by mouth once daily
Other Name: Imbruvica
Other Name: Aliqopa
Capsule, taken by mouth twice daily
Other Name: Calquence
- Complete response (CR) Rate [ Time Frame: 6 months ]Rate of complete response (CR) by 2018 IWCLL criteria following the addition of six months of copanlisib to the therapy of patients with SD or PR or PR-L on ibrutinib or acalabrutinib in the relapsed/refractory setting.
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE ver. 5.0. [ Time Frame: 6 months ]Adverse events will be collected and reported as percentages
- Duration of Response (DOR) [ Time Frame: 3 years ]Legnth of time the patients respond to therapy
- Progression-free Survival (PFS) [ Time Frame: 3 years ]The time from registration to progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
- Overall Survival (OS) [ Time Frame: 3 years ]The time from registration to death due to any cause or censored at date last known alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685915
|Contact: Kim Pena del Aguilafirstname.lastname@example.org|
|Contact: Jillian Foreman||877-DF-TRIALemail@example.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Kim Pena del Aguila 857-215-1707 firstname.lastname@example.org|
|Principal Investigator: Inhye Ahn, MD|
|Principal Investigator:||Inhye Ahn, MD||Dana-Farber Cancer Institute|