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New mantle cell trials launching


 

SUMMARY FROM CLINICALTRIALS.GOV

At least four new trials in mantle cell lymphoma (MCL) are preparing to launch, according to records posted on Clinicaltrials.gov.

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The range of new studies are occurring around the world and examine the association of lenalidomide with tumor flare reaction, maintenance ixazomib for newly diagnosed patients, the addition of bortezomib to ibrutinib in ibrutinib-released patients, and acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in untreated patients.

Acalabrutinib With Alternating Cycles of Bendamustine/Rituximab and Cytarabine/Rituximab for Untreated Mantle Cell Lymphoma (NCT03623373) is slated to start on Oct. 31, 2018, and be completed in 2025.

The trial, which is not yet recruiting, is estimated to enroll 15 participants. The phase 1 study will be aimed at evaluating the efficacy and safety of acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab in MCL patients who are treatment naive. The primary outcome measure is stem cell mobilization success rate in patients treated with this regimen. The phase 1 study is preparation for a larger cooperative group trial that aims to achieve a standard induction regimen for MCL in transplant-eligible patients.

The study is sponsored by Washington University, St. Louis, in collaboration with Acerta Pharma.

Ibrutinib-relapsed MCL

Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma (NCT03617484) is scheduled to start in September 2018 and be completed in 2021. It is estimated to enroll 35 patients but is not yet recruiting.

The phase 2, open-label study is aimed at evaluating the efficacy of the ibrutinib/bortezomib in MCL patients who relapsed on ibrutinib alone. The primary outcome is the overall response rate at 6 months based on the Lugano criteria.

The trial is sponsored by the University of Michigan, Ann Arbor.

Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma (NCT03616782) launched in August 2018 and is expected to be completed in 2022.

The phase 2 trial is expected to enroll 98 patients but has not started recruitment yet. In the open-label, multicenter study, newly diagnosed MCL patients will receive induction chemotherapy and those who achieve at least a partial response will be eligible to move on to the experimental phase – maintenance ixazomib. At least 8 weeks after completing induction, patients can receive ixazomib orally on days 1, 8, and 15 for 4 weeks. Treatment repeats every 4 weeks for up to 2 years unless the disease progresses or there is unacceptable toxicity. The primary outcome measure is 2-year progression-free survival.

The trial is sponsored by Ho Sup Lee, MD, of Kosin University Gospel Hospital in Busan, South Korea, in collaboration with Takeda.

PASS MCL-005

The Noninterventional Study in Patients With Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) to Investigate the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden, called PASS MCL-005 (NCT03647124) is slated to start at the end of September 2018 and wrap up in 2026.

The retrospective cohort study will rely on data collection from Nordic registries and national health databases. The researchers will analyze records from sites where lenalidomide treatment for relapsed/refractory MCL is reimbursed. The estimated enrollment is 560 participants.

The primary goal is to quantify and characterize the event of tumor flare reaction by tumor burden in relapsed/refractory MCL patients who were treated with lenalidomide in a real-world setting.

The European-based study is sponsored by Celgene.

mschneider@mdedge.com

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