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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001398-17 | EudraCT Number |
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This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navitoclax + ruxolitinib (Cohort 1a) | Experimental | Participants must have received ruxolitinib for at least 12 weeks and on stable dose of ≥10 mg tablets orally twice daily (BID) for ≥8 weeks prior to the 1st dose of navitoclax. Navitoclax tablets are administered once daily (QD) at a starting dose of 50 mg. This was increased after approximately ≥7 days to next dose level if platelet count is ≥75 × 10^9/L up to a maximum dose of navitoclax 300 mg QD. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
| Navitoclax + ruxolitinib (Cohort 1b) | Experimental | Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
| Navitoclax (Cohort 2) | Experimental | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Tablet; Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT). | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0. Participants complete a symptom diary and rate the following seven MF symptoms: fatigue, night sweats, abdominal discomfort, pruritus, pain under the ribs on the left side, early satiety, and bone pain daily using a scale from 0 (absent) to 10 (worst imaginable), and the scores are averaged over 7 days, with a minimum of 4 days required to calculate the average score. Participants for whom a valid average score cannot be calculated either at baseline or post-baseline are considered non-responders. The TSS reflects the sum of the scores of these symptoms, for a maximum possible score of 70 (i.e., most severe symptom experience). |
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Inclusion Criteria:
Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
Participant must be ineligible due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry.
Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2.
Prior treatment must meet at least one of the following criteria:
Prior or current treatment with ruxolitinib and no prior treatment with a Bromodomain and Extra-Terminal motif (BET) proteins inhibitor or another Janus Kinase 2 (JAK-2) inhibitor, and meet all of the following criteria:
Ruxolitinib treatment must meet at least one of the following criteria:
If receiving ruxolitinib at the time of screening, must currently be on a stable dose >=10 mg twice daily of ruxolitinib for >=4 weeks prior to the 1st dose of navitoclax.
Participant has at least 2 symptoms each with a score >=3 or a total score of >=12, as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days during screening prior to study drug dosing; OR
Prior treatment with a JAK-2 inhibitor and meet one of the following criteria:
No prior treatment with a JAK-2 or BET inhibitor.
Participant has splenomegaly as defined in the protocol.
Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Cente /ID# 165464 | Birmingham | Alabama | 35217 | United States | ||
| TOI Clinical Research /ID# 222546 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41846295 | Derived | Passamonti F, Foran JM, Tandra A, De Stefano V, Fox ML, Mattour A, McMullin MF, Perkins AC, Rodriguez-Macias G, Sibai HA, Polepally AR, Sun Y, Chopra AS, Harb JG, Qin Q, Potluri J, How J. Preliminary Safety and Efficacy of Navitoclax Plus Ruxolitinib in Janus Kinase Inhibitor-Naive Patients With Myelofibrosis From the Multicenter, Open-Label, Phase 2 Study (REFINE). Hematol Oncol. 2026 Mar;44(2):e70180. doi: 10.1002/hon.70180. | |
| 40454409 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Participants enrolled in Cohort 1a must have received ruxolitinib therapy for at least 12 weeks and currently be on a stable dose of ≥10 mg twice daily of ruxolitinib. For Cohort 1b, participants must have received prior treatment with ruxolitinib. For Cohort 2, participants must have received prior treatment with a JAK-2 inhibitor. For Cohort 3, participants must not have received prior treatment with a JAK-2 inhibitor or BET inhibitor.
This trial was conducted at 57 sites in 13 countries./territories.
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| ID | Title | Description |
|---|---|---|
| FG000 | Navitoclax + Ruxolitinib (Cohort 1a) | Participants must have received ruxolitinib for at least 12 weeks and on stable dose of ≥10 mg tablets orally twice daily (BID) for ≥8 weeks prior to the 1st dose of navitoclax. Navitoclax tablets are administered once daily (QD) at a starting dose of 50 mg. This was increased after approximately ≥7 days to next dose level if platelet count is ≥75 × 10^9/L up to a maximum dose of navitoclax 300 mg QD. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2021 | Feb 24, 2025 |
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|
| Navitoclax + ruxolitinib (Cohort 3) | Experimental | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
|
| Navitoclax | Drug | Film-coated tablet; Oral |
|
|
| Baseline, Week 24 |
| Percentage of Participants Achieving Anemia Response | For a participant who is transfusion independent (TI) at Baseline with hemoglobin value < 10 g/dL, anemia response is achieved if the post-Baseline hemoglobin level increases by ≥2 g/dL without receiving packed red blood cells (PRBC) transfusion (for any reason) within 2 weeks and without any erythropoietin or mimetics within the last 4 weeks prior to the increase in hemoglobin level by ≥2g/dL was observed. Hemoglobin values more than 30 days after the last dose of study treatment or after the start of post-study treatment or disease progression, whichever is earlier, will not be considered in the analysis of anemia response. For a participant who is transfusion dependent (TD) at Baseline, anemia response is defined as a period of at least 12 consecutive weeks without PRBC transfusion at any time after the first dose of study drug and on or prior to 30 days post last dose of study drug, the start of post-study treatment, disease progression or death, whichever occurs earlier. | Up to 254 weeks |
| Percentage of Participants With ≥ 1 Grade Reduction From Baseline in Fibrosis Grade At Any Time | Bone marrow grading is assessed according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. | Up to 254 weeks |
| Time to First Reduction in Fibrosis Grade | Grade of bone marrow fibrosis was assessed by investigators according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. The time to first achieving a reduction of at least 1 grade in bone marrow fibrosis from Baseline was summarized. | Up to 254 weeks |
| Cerritos |
| California |
| 90703-2679 |
| United States |
| City of Hope /ID# 221395 | Duarte | California | 91010 | United States |
| Moores Cancer Center at UC San Diego /ID# 164084 | La Jolla | California | 92093 | United States |
| Long Beach Memorial Medical Ct /ID# 230148 | Long Beach | California | 90806-1701 | United States |
| University of Southern California /ID# 164095 | Los Angeles | California | 90033 | United States |
| Colorado Blood Cancer Institute /ID# 224250 | Denver | Colorado | 80218 | United States |
| Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548 | Jacksonville | Florida | 32207-8432 | United States |
| Mayo Clinic /ID# 164201 | Jacksonville | Florida | 32224 | United States |
| Moffitt Cancer Center /ID# 164082 | Tampa | Florida | 33612-9416 | United States |
| University of Chicago Medicine /ID# 164115 | Chicago | Illinois | 60637-1426 | United States |
| Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536 | Normal | Illinois | 61761 | United States |
| Indiana Blood & Marrow Transpl /ID# 165075 | Indianapolis | Indiana | 46237 | United States |
| Duplicate_American Oncology Partners of Maryland, PA /ID# 231299 | Bethesda | Maryland | 20817 | United States |
| Dana-Farber Cancer Institute /ID# 162675 | Boston | Massachusetts | 02215 | United States |
| University of Massachusetts - Worcester /ID# 222547 | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Hospital /ID# 162682 | Detroit | Michigan | 48202 | United States |
| Ascension Providence Southfield Cancer Center /ID# 223876 | Southfield | Michigan | 48075-3707 | United States |
| MidAmerica Division, Inc. /ID# 222058 | Kansas City | Missouri | 64132 | United States |
| Weill Cornell Medical College /ID# 162679 | New York | New York | 10065 | United States |
| The Ohio State University /ID# 217402 | Columbus | Ohio | 43210-1280 | United States |
| Bend Memorial Clinic /ID# 224184 | Bend | Oregon | 97701 | United States |
| West Penn Hospital /ID# 222618 | Pittsburgh | Pennsylvania | 15224-1722 | United States |
| Duplicate_Medical University of South Carolina /ID# 222597 | Charleston | South Carolina | 29425 | United States |
| Prairie Lakes Healthcare System /ID# 224358 | Watertown | South Dakota | 57201 | United States |
| Tennessee Oncology-Nashville Centennial /ID# 221410 | Nashville | Tennessee | 37203-1632 | United States |
| Texas Oncology - West Texas /ID# 224784 | Abilene | Texas | 79606 | United States |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159 | Dallas | Texas | 75246-2003 | United States |
| Oncology Consultants /ID# 230930 | Houston | Texas | 77030-3306 | United States |
| MD Anderson Cancer Center at Texas Medical Center /ID# 162683 | Houston | Texas | 77030-4000 | United States |
| University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094 | San Antonio | Texas | 78229 | United States |
| Utah Cancer Specialists Salt Lake Clinic /ID# 222806 | Salt Lake City | Utah | 84106 | United States |
| University of Utah /ID# 164116 | Salt Lake City | Utah | 84112-5500 | United States |
| The Kinghorn Cancer Centre /ID# 214657 | Darlinghurst | New South Wales | 2010 | Australia |
| Barwon Health /ID# 222430 | Geelong | Victoria | 3220 | Australia |
| Peter MacCallum Cancer Ctr /ID# 218352 | Melbourne | Victoria | 3000 | Australia |
| The Alfred Hospital /ID# 215545 | Melbourne | Victoria | 3004 | Australia |
| Fiona Stanley Hospital /ID# 216809 | Murdoch | Western Australia | 6150 | Australia |
| Duplicate_University of Alberta Hospital - Division of Hematology /ID# 217698 | Edmonton | Alberta | T6G 2B7 | Canada |
| University Health Network_Princess Margaret Cancer Centre /ID# 214483 | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Center Research Institute /ID# 223976 | Montreal | Quebec | H4A 3J1 | Canada |
| Clinical Hospital Dubrava /ID# 230504 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicka bolnica Merkur /ID# 230599 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Zagreb /ID# 230602 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki Bolnicki Centar (KBC) Split /ID# 230601 | Split | Split-Dalmatia County | 21000 | Croatia |
| General Hospital of Athens Laiko /ID# 230394 | Athens | Attica | 11527 | Greece |
| Duplicate_University General Hospital Attikon /ID# 230395 | Athens | Attica | 12462 | Greece |
| Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 230585 | NyÃregyháza | Szabolcs-Szatmár-Bereg | 4400 | Hungary |
| Semmelweis Egyetem /ID# 230518 | Budapest | 1085 | Hungary |
| Duplicate_Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 230306 | Budapest | 1097 | Hungary |
| Hadassah Medical Center-Hebrew University /ID# 230310 | Jerusalem | Jerusalem | 91120 | Israel |
| Galilee Medical Center /ID# 230397 | Nahariya | Northern District | 2210001 | Israel |
| Assuta Ashdod Medical Center /ID# 230396 | Ashdod | Southern District | 7747629 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 230311 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 230012 | Bologna | Emilia-Romagna | 40138 | Italy |
| Azienda Ospedaliero Universitaria Careggi /ID# 214555 | Florence | Firenze | 50134 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553 | Rome | Roma | 00168 | Italy |
| ASST Papa Giovanni XXIII /ID# 214900 | Bergamo | 24127 | Italy |
| ASST degli Spedali Civili di Brescia /ID# 230420 | Brescia | 25123 | Italy |
| AOU Policlinico G. Rodolico - San Marco /ID# 214549 | Catania | 95123 | Italy |
| Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 230011 | Reggio Calabria | 89125 | Italy |
| ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 214551 | Varese | 21100 | Italy |
| Fujita Health University Hospital /ID# 221539 | Toyoake | Aichi-ken | 470-1192 | Japan |
| Aomori Prefectural Central Hospital /ID# 221773 | Aomori | Aomori | 030-8553 | Japan |
| Kyushu University Hospital /ID# 222691 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Sapporo Hokuyu Hospital /ID# 222693 | Sapporo | Hokkaido | 003-0006 | Japan |
| Kansai Medical University Hospital /ID# 222690 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Kindai University Hospital /ID# 222689 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Duplicate_Dokkyo Medical University Saitama Medical Center /ID# 222332 | Koshigaya-shi | Saitama | 343-8555 | Japan |
| Juntendo University Hospital /ID# 221484 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Nippon Medical School Hospital /ID# 222692 | Bunkyo-ku | Tokyo | 113-8602 | Japan |
| University of Yamanashi Hospital /ID# 221700 | Chuo-shi | Yamanashi | 409-3821 | Japan |
| VA Caribbean Healthcare System /ID# 222416 | San Juan | 00921-3201 | Puerto Rico |
| Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544 | San Juan | 00927 | Puerto Rico |
| Seoul National University Hospital /ID# 230380 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Samsung Medical Center /ID# 230381 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Hospital Universitario Germans Trias i Pujol /ID# 214704 | Badalona | Barcelona | 08916 | Spain |
| Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718 | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 222415 | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 214676 | Madrid | 28007 | Spain |
| CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719 | Madrid | 28027 | Spain |
| Hospital Universitario 12 de Octubre /ID# 214710 | Madrid | 28041 | Spain |
| Hospital Universitario Virgen de la Victoria /ID# 214709 | Málaga | 29010 | Spain |
| Hospital Regional Universitario de Malaga /ID# 230858 | Málaga | 29011 | Spain |
| Kaohsiung Chang Gung Memorial Hospital /ID# 230371 | Kaohsiung City | Kaohsiung | 833 | Taiwan |
| National Cheng Kung University Hospital /ID# 230372 | Tainan | 704 | Taiwan |
| Guys and St Thomas NHS Foundation Trust /ID# 164110 | London | Greater London | SE1 9RT | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust /ID# 214503 | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Belfast Health and Social Care Trust /ID# 216991 | Belfast | BT9 7AB | United Kingdom |
| The Christie Hospital /ID# 164111 | Manchester | M20 4BX | United Kingdom |
| Aneurin Bevan University Health Board /ID# 230332 | Newport | NP18 3XQ | United Kingdom |
| Derived |
| Pemmaraju N, Somervaille TCP, Palandri F, Harrison C, Komrokji RS, Perkins A, Ayala Diaz RM, Lavie D, Tomita A, Feng Y, Qin Q, Harb J, Polepally AR, Potluri J, Garcia JS. Addition of navitoclax to ruxolitinib for patients with myelofibrosis with progression or suboptimal response. Blood Neoplasia. 2024 Nov 2;2(1):100056. doi: 10.1016/j.bneo.2024.100056. eCollection 2025 Feb. |
| 35576960 | Derived | Pemmaraju N, Garcia JS, Potluri J, Harb JG, Sun Y, Jung P, Qin QQ, Tantravahi SK, Verstovsek S, Harrison C. Addition of navitoclax to ongoing ruxolitinib treatment in patients with myelofibrosis (REFINE): a post-hoc analysis of molecular biomarkers in a phase 2 study. Lancet Haematol. 2022 Jun;9(6):e434-e444. doi: 10.1016/S2352-3026(22)00116-8. Epub 2022 May 13. |
| 35180010 | Derived | Harrison CN, Garcia JS, Somervaille TCP, Foran JM, Verstovsek S, Jamieson C, Mesa R, Ritchie EK, Tantravahi SK, Vachhani P, O'Connell CL, Komrokji RS, Harb J, Hutti JE, Holes L, Masud AA, Nuthalapati S, Potluri J, Pemmaraju N. Addition of Navitoclax to Ongoing Ruxolitinib Therapy for Patients With Myelofibrosis With Progression or Suboptimal Response: Phase II Safety and Efficacy. J Clin Oncol. 2022 May 20;40(15):1671-1680. doi: 10.1200/JCO.21.02188. Epub 2022 Feb 18. |
| FG001 | Navitoclax + Ruxolitinib (Cohort 1b) | Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| FG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| FG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): all participants who take at least one dose of navitoclax
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Navitoclax + Ruxolitinib (Cohort 1a) | Participants must have received ruxolitinib for at least 12 weeks and on stable dose of ≥10 mg tablets orally twice daily (BID) for ≥8 weeks prior to the 1st dose of navitoclax. Navitoclax tablets are administered once daily (QD) at a starting dose of 50 mg. This was increased after approximately ≥7 days to next dose level if platelet count is ≥75 × 10^9/L up to a maximum dose of navitoclax 300 mg QD. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| BG001 | Navitoclax + Ruxolitinib (Cohort 1b) | Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| BG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| BG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 | Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT). | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Total System Score (TSS) at Week 24 | TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0. Participants complete a symptom diary and rate the following seven MF symptoms: fatigue, night sweats, abdominal discomfort, pruritus, pain under the ribs on the left side, early satiety, and bone pain daily using a scale from 0 (absent) to 10 (worst imaginable), and the scores are averaged over 7 days, with a minimum of 4 days required to calculate the average score. Participants for whom a valid average score cannot be calculated either at baseline or post-baseline are considered non-responders. The TSS reflects the sum of the scores of these symptoms, for a maximum possible score of 70 (i.e., most severe symptom experience). | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Anemia Response | For a participant who is transfusion independent (TI) at Baseline with hemoglobin value < 10 g/dL, anemia response is achieved if the post-Baseline hemoglobin level increases by ≥2 g/dL without receiving packed red blood cells (PRBC) transfusion (for any reason) within 2 weeks and without any erythropoietin or mimetics within the last 4 weeks prior to the increase in hemoglobin level by ≥2g/dL was observed. Hemoglobin values more than 30 days after the last dose of study treatment or after the start of post-study treatment or disease progression, whichever is earlier, will not be considered in the analysis of anemia response. For a participant who is transfusion dependent (TD) at Baseline, anemia response is defined as a period of at least 12 consecutive weeks without PRBC transfusion at any time after the first dose of study drug and on or prior to 30 days post last dose of study drug, the start of post-study treatment, disease progression or death, whichever occurs earlier. | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax; participants who were Baseline transfusion independent with baseline hemoglobin of ≥10 g/dL were excluded from the analysis since they were not evaluable for anemia response. Missing post-Baseline anemia response in Full Analysis Set applicable to evaluation of anemia response are considered as non-responders of anemia response. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 254 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥ 1 Grade Reduction From Baseline in Fibrosis Grade At Any Time | Bone marrow grading is assessed according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax; participants with missing bone marrow fibrosis grade (either Baseline or post-Baseline) or those with bone marrow fibrosis Grade 0 at Baseline were excluded from the analysis for the change in bone marrow fibrosis grade | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 254 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Reduction in Fibrosis Grade | Grade of bone marrow fibrosis was assessed by investigators according to the European Consensus Grading System. The 4-point grading scale ranges from MF-0, which corresponds to normal bone marrow, to MF-3, diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. The time to first achieving a reduction of at least 1 grade in bone marrow fibrosis from Baseline was summarized. | Full Analysis Set (FAS): all participants who take at least one dose of navitoclax; participants with Baseline bone marrow fibrosis grade >0 and post-Baseline bone marrow fibrosis grade are included in the analysis | Posted | Median | Full Range | weeks | Up to 254 weeks |
|
All-cause mortality and adverse events tables include events reported from the time of informed consent to the end of the study. Median time on follow-up was for 76.1 months for Navitoclax + ruxolitinib (Cohort 1a); 41.9 months for Navitoclax + ruxolitinib (Cohort 1b); 40.2 months for Navitoclax (Cohort 2); and 44.2 months for Navitoclax + ruxolitinib (Cohort 3).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Navitoclax + Ruxolitinib (Cohort 1a) | Participants must have received ruxolitinib for at least 12 weeks and on stable dose of ≥10 mg tablets orally twice daily (BID) for ≥8 weeks prior to the 1st dose of navitoclax. Navitoclax tablets are administered once daily (QD) at a starting dose of 50 mg. This was increased after approximately ≥7 days to next dose level if platelet count is ≥75 × 10^9/L up to a maximum dose of navitoclax 300 mg QD. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). | 20 | 34 | 21 | 34 | 34 | 34 |
| EG001 | Navitoclax + Ruxolitinib (Cohort 1b) | Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). | 39 | 91 | 35 | 91 | 91 | 91 |
| EG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). | 18 | 34 | 18 | 34 | 34 | 34 |
| EG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). | 10 | 32 | 12 | 32 | 32 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SPLENIC INFARCTION | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CARDIAC DISORDER | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GASTRIC VARICES | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GASTROINTESTINAL ANGIODYSPLASIA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BILIARY COLIC | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PORTAL VEIN THROMBOSIS | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ANORECTAL INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ENTEROBACTER SEPSIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| EPSTEIN-BARR VIRUS INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| GIARDIASIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| IMPLANT SITE CELLULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| MYCOBACTERIAL INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ORAL INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PARAINFLUENZAE VIRUS INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PNEUMONIA MORAXELLA | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| IMMUNISATION REACTION | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| LISFRANC FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| NEUROENDOCRINE CARCINOMA OF THE SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| RENAL CELL CARCINOMA STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| TRANSFORMATION TO ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| INTRACRANIAL HAEMATOMA | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PELVIC HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VASCULITIS | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| EOSINOPHILIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SPLENOMEGALY | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VITREOUS FLOATERS | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| EARLY SATIETY | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| GENITAL HERPES | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| CARDIAC MURMUR | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FOLATE DEFICIENCY | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| SEBORRHOEIC KERATOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| TASTE DISORDER | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| AQUAGENIC PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2023 | Feb 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D013163 | Splenomegaly |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| C528561 | navitoclax |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 |
| Navitoclax + Ruxolitinib (Cohort 1b) |
Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
|
| OG001 | Navitoclax + Ruxolitinib (Cohort 1b) | Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
|
Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
|
Those receiving ruxolitinib at Screening must be on a stable dose ≥10 mg tablets orally twice daily (BID) for ≥ 4 weeks prior to 1st dose of navitoclax. Those not receiving ruxolitinib at Screening received 10 mg ruxolitinib BID starting on Day 1. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose was increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first).
| OG002 | Navitoclax (Cohort 2) | Participants must have received prior treatment with a Janus Kinase 2 (JAK-2) inhibitor. Those with Baseline platelet count >150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 200 mg. Those with a Baseline platelet count ≤150 × 10^9/L initiated navitoclax film-coated tablets orally once daily (QD) at the starting dose of 100 mg, which could be increased to 200 mg once daily after 7 days provided the platelet count is ≥75 × 10^9/L. Navitoclax didn't exceed 200 mg QD for the first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of the Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
| OG003 | Navitoclax + Ruxolitinib (Cohort 3) | Prior treatment with a Janus Kinase 2 (JAK-2) or Bromodomain and Extra-Terminal motif (BET) proteins inhibitor was prohibited. Ruxolitinib tablets administered orally twice daily (BID) based on Baseline platelet count as per the local approved label. Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (>150 × 10^9/L starting dose of 200 mg; ≤150 × 10^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 24 disease assessment, navitoclax dose may be increased to 300 mg QD at discretion of Investigator for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Participants continued their treatment until the end of clinical benefit, unacceptable toxicity, or they met other protocol criteria for discontinuation (whichever occurred first). |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|