{"id":613,"date":"2019-08-27T20:51:26","date_gmt":"2019-08-27T20:51:26","guid":{"rendered":"https:\/\/clladvocates.nz\/?p=613"},"modified":"2019-09-12T01:29:22","modified_gmt":"2019-09-12T01:29:22","slug":"ibrutinib-rituximab-for-patients-with-cll-superior-to-standard-chemoimmunotherapy-2","status":"publish","type":"post","link":"https:\/\/clladvocates.nz\/?p=613","title":{"rendered":"Cirmtuzumab-Imbruvica Combo Trial Enrolling CLL, SLL Patients for Phase 2"},"content":{"rendered":"

[vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″][vc_column width=”1\/1″][vc_custom_heading heading_semantic=”h1″ text_size=”h1″]<\/p>\n

Cirmtuzumab-Imbruvica Combo Trial Enrolling CLL, SLL Patients for Phase 2<\/p>\n

[\/vc_custom_heading][vc_column_text]This article was originally published on Lymphoma News Today<\/a><\/p>\n

Following promising early efficacy results for a\u00a0cirmtuzumab<\/a>\u2013Imbruvica<\/a>\u00a0treatment combo, a Phase 2\u00a0clinical trial<\/a>\u00a0has now been opened to people with\u00a0chronic lymphocytic leukemia\/small lymphocytic lymphoma<\/a>\u00a0(CLL\/SLL).<\/p>\n

The opening of this randomized trial was based on the promising results seen in the prior Phase 1 stage, in which 100% of the first nine CLL\/SLL patients responded to treatment with\u00a0Oncternal Therapeutics<\/a>\u2018 investigational therapy\u00a0cirmtuzumab<\/a>\u00a0in combination with\u00a0Imbruvica<\/a>\u00a0(ibrutinib<\/a>).<\/p>\n

The Phase 2\u00a0clinical trial<\/a>\u00a0is now open to an additional 90 patients with CLL\/SLL. Participants will be randomly selected to receive the combination of cirmtuzumab plus Imbruvica, or Imbruvica alone. More information on enrollment can be found on the trial\u2019s page\u00a0here<\/a>.<\/p>\n

Imbruvica, by\u00a0Janssen<\/a>\u00a0and\u00a0AbbVie<\/a>, is the standard of care for people with CLL\/SLL and\u00a0mantle cell lymphoma<\/a>\u00a0(MCL) who have received at least one prior therapy. The molecule binds permanently to the\u00a0Bruton\u2019s tyrosine kinase protein<\/a>, which is key in the growth and proliferation of B-cell cancers.<\/p>\n

Cirmtuzumab is an antibody that blocks the\u00a0ROR1 receptor<\/a>\u00a0in tumor cells. ROR1 is rarely seen in healthy cells, but in tumor cells it works as a receptor for growth signals, helping the tumor grow and survive.<\/p>\n

Researchers have been testing a combination of these two treatments in patients with CLL\/SLL and MCL who have failed prior therapies but have not received a prior BTK inhibitor.<\/p>\n

The CIRLL Phase 1b\/2 trial (NCT03420183<\/a>) was first designed in three parts. First, participants received ascending doses of cirmtuzumab alone, followed by a combination of cirmtuzumab and Imbruvica. The goal was to determine the optimal dosing regimen for further testing.<\/p>\n

The recommended dosing regimen then was further tested in part 2 (Phase 1b).\u00a0In total, 66 patients were included in these two Phase 1 parts.<\/p>\n

Preliminary data from these parts were presented in a poster, \u201cPhase 1\/2 Trial of Cirmtuzumab and Ibrutinib: Planned Analysis of Phase 1 CLL Cohorts<\/a>,<\/u>\u201d at\u00a0the American Society of Clinical Oncology (ASCO) annual meeting<\/a>, held in the spring in Chicago.<\/p>\n

The analysis included the first 12 CLL\/SLL patients, for whom the treatment was safe and well-tolerated. The therapy led to an objective response rate of 91.7%. Three of the 11 patients who responded had clinical or confirmed complete responses.<\/p>\n

Researchers noted that all nine patients who completed 12 weeks of treatment in part 2 \u2014 in which participants received a recommended dose of 600 mg cirmtuzumab plus 420 mg Imbruvica \u2014 achieved a response to treatment.<\/p>\n

Preliminary data also was presented for the first six MCL patients. One participant, whose disease had returned after a stem cell transplant, had a complete response after three months of treatment, which was maintained at least until month 11. The treatment also led to the resolution of a tumor in the chest.<\/p>\n

The findings in CLL\/SLL participants led researchers to open a third part (Phase 2), to compare the safety and efficacy of the combination versus Imbruvica alone. The main goal is to compare the percentage of patients achieving a complete response.<\/p>\n

\u201cWe are very pleased to be opening the randomized Phase 2 portion of the CIRLL study for patients with CLL and continue to be encouraged by the interim results from the study for both patients with CLL and patients with\u00a0mantle cell lymphoma<\/a>,\u201d James Breitmeyer, MD, PhD, president and CEO of Oncternal, said in a\u00a0press release<\/a>.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

Following promising early efficacy results for a cirmtuzumab\u2013Imbruvica treatment combo, a Phase 2 clinical trial has now been opened to people with chronic lymphocytic leukemia\/small lymphocytic lymphoma (CLL\/SLL).<\/p>\n","protected":false},"author":1,"featured_media":657,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[12],"tags":[],"class_list":["post-613","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-media"],"jetpack_featured_media_url":"https:\/\/clladvocates.nz\/wp-content\/uploads\/2019\/08\/Enrol.jpg","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts\/613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=613"}],"version-history":[{"count":3,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts\/613\/revisions"}],"predecessor-version":[{"id":658,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/posts\/613\/revisions\/658"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=\/wp\/v2\/media\/657"}],"wp:attachment":[{"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=613"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=613"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clladvocates.nz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}