Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AbbVie
Study ID
NCT04468984
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Myelofibrosis (MF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navitoclax — DRUG
    Tablet; Oral
  • Ruxolitinib — DRUG
    Tablet; Oral
  • Best Available Therapy (BAT) — DRUG
    Tablet/Capsule; Oral or Solution for Subcutaneous Injection

Study Details

Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. In Arm C, participants will receive navitoclax tablet by mouth once daily. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

Key Dates

Start date
Aug 31, 2020
Status verified
Jan 2026
Primary completion
Jan 29, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Navitoclax + Ruxolitinib
    Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
  • Active Comparator: Arm B: Best Available Therapy (BAT)
    Participants will receive one of the BAT options, per the investigator's discretion.
  • Experimental: Arm C: Continued Access for Navitoclax
    Participants will receive navitoclax tablets once daily.

Primary Outcome Measure

Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) [ Time Frame: At Week 24 ]

Locations (41)

FacilityCityStateZIPSite coordinators
Ironwood Cancer & Res Ctr /ID# 222162ChandlerArizona85224-5665-
Highlands Oncology Group, PA /ID# 221826SpringdaleArkansas72762-
City of Hope /ID# 218996DuarteCalifornia91010-
Providence - St. Jude Medical Center /ID# 271382FullertonCalifornia92835-
Moores Cancer Center /ID# 271596La JollaCalifornia92037-
Moores Cancer Center at UC San Diego /ID# 219009La JollaCalifornia92093-
Long Beach Memorial Medical Ct /ID# 224542Long BeachCalifornia90806-1701-
Icri /Id# 221967WhittierCalifornia90603-
St. Mary's Hospital Regional Cancer Center /ID# 224229Grand JunctionColorado81501-6132-
Augusta University Georgia Cancer Center /ID# 219051AugustaGeorgia30912-0003-
Columbus Regional Research Institute /ID# 224410ColumbusGeorgia31904-8915-
University of Chicago Medical Center /ID# 271373ChicagoIllinois60637-
Northwest Oncology & Hematology - Elk Grove Village /ID# 222818Elk Grove VillageIllinois60007-3361-
Loyola University Medical Ctr /ID# 219048MaywoodIllinois60153-
Indiana Blood & Marrow Transpl /ID# 221587IndianapolisIndiana46237-
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777New OrleansLouisiana70121-
Tulane Medical Center - New Orleans /ID# 222940New OrleansLouisiana70112-2600-
American Oncology Partners of Maryland /ID# 222836BethesdaMaryland20817-
Dana-Farber Cancer Institute /ID# 218998BostonMassachusetts02215-
University of Michigan /ID# 218463Ann ArborMichigan48109-
Henry Ford Hospital /ID# 221190DetroitMichigan48202-
William Beaumont Hospital /ID# 222705Royal OakMichigan48073-6710-
Saint Louis University Cancer Center /ID# 222287St LouisMissouri63110-2539-
Summit Medical Group-Florham Park /ID# 222620Florham ParkNew Jersey07932-1049-
Hackensack Univ Med Ctr /ID# 219047HackensackNew Jersey07601-
The Cancer Institute at St. Francis Hospital /ID# 231782GreenvaleNew York11548-1219-
Manhattan Hematology Oncology MHO Associates /ID# 223193New YorkNew York10016-6028-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081New YorkNew York10065-6007-
Atrium Health Wake Forest Baptist Medical Center /ID# 222899Winston-SalemNorth Carolina27157-0001-
MetroHealth Medical Center /ID# 222650ClevelandOhio44109-
Pennsylvania Cancer Specialists & Research Institute /ID# 271376GettysburgPennsylvania17325-
Fox Chase Cancer Center /ID# 223955PhiladelphiaPennsylvania19111-
Hospital of the University of Pennsylvania /ID# 219001PhiladelphiaPennsylvania19104-4238-
Texas Oncology - Abilene - Antilley Road /ID# 271379AbileneTexas79606-
Duplicate_Houston Methodist Hospital /ID# 223103HoustonTexas77030-
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942San AntonioTexas78229-
Utah Cancer Specialists Salt Lake Clinic /ID# 221962Salt Lake CityUtah84106-
Virginia Cancer Specialists - Fairfax /ID# 223016FairfaxVirginia22031-
Providence Everett /ID# 223130EverettWashington98201-
Yakima Valley Memorial Hosp /ID# 224368YakimaWashington98902-6388-
HSHS St. Vincent Hospital /ID# 224468Green BayWisconsin54301-

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Ironwood Cancer & Res Ctr· Chandler, AZHighlands Oncology Group, PA· Springdale, ARCity of Hope· Duarte, CAProvidence - St. Jude Medical Center· Fullerton, CAMoores Cancer Center· La Jolla, CAMoores Cancer Center at UC San Diego· La Jolla, CA

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