Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
NCT ID: NCT05423691
Last Updated: 2025-04-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-12-27
Study Completion Date
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis
NCT03069326
Myelofibrosis
ACTIVE_NOT_RECRUITING
PHASE2
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
NCT05280509
Myelofibrosis
Primary Myelofibrosis
Post-PV MF
+1 more
RECRUITING
PHASE1/PHASE2
Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis
NCT02784496
Myelofibrosis
COMPLETED
PHASE2
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
NCT04097821
Myelofibrosis
TERMINATED
PHASE1/PHASE2
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
NCT00732186
Leukemia, Myeloid, Chronic
WITHDRAWN
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Safety Run-in
The study will employ a 3+3+3 design to assess the safety and tolerability of the treatment based on treatment-limiting toxicities (TLTs) occurring up to 1 Cycle (28 days) after the first infusion.
2. Expansion
After a total of 9 participants completed 28 days and are evaluated for tolerability in the safety run-in phase, additional participants may be included in the expansion cohort in order to have approximately 24 evaluable myelofibrosis
The study will employ a 3+3+3 design to assess the safety and tolerability of the treatment based on treatment-limiting toxicities (TLTs) occurring up to 1 Cycle (28 days) after the first infusion.
2. Expansion
After a total of 9 participants completed 28 days and are evaluated for tolerability in the safety run-in phase, additional participants may be included in the expansion cohort in order to have approximately 24 evaluable myelofibrosis
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Myelofibrosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a single-arm study consisting of a safety run-in (3+3+3 design) followed by an expansion cohort after completion of safety run-in data is evaluated for tolerability in the safety.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
CK0804 will be administered intravenously (IV) 100 million Treg Cells every 28 days up to 6 infusions.
Group Type
EXPERIMENTAL
CK0804
Intervention Type
DRUG
CK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CK0804
CK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
2. Age above 18 years inclusive at the time of signing the ICF.
3. Participants who fulfill the diagnostic criteria of myelofibrosis including primary myelofibrosis and myelofibrosis arising from polycythemia vera and essential thrombocythemia
4. Life expectancy is greater than 6 months.
5. Subject has been receiving ruxolitinib therapy, is unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator; AND meeting the following criteria: receiving ruxolitinib \>3 months prior to enrollment; AND stable dose for 8 weeks before starting therapy with CK0804
6. Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of:
* presence of grade ≥2 anemia or thrombocytopenia or neutropenia, OR
* presence of disease-related symptoms, as determined by a Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN SAF TSS) score of ≥10 points, OR
* documented splenomegaly of at least 5 cm below the costal margin as measured by physical examination or splenomegaly as documented by ultrasound or MRI.
7. Willingness to avoid pregnancy or fathering children based on the criteria below
* Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last study treatment dose and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing should be communicated to the participants and their understanding confirmed.
* Women of childbearing potential must have a negative serum pregnancy test at screening before the first dose (within 3 days of the first study treatment dose) and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through the safety follow-up visit and must not donate oocytes during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed,
* Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.
8. ECOG performance status of 0 to 2
2. Age above 18 years inclusive at the time of signing the ICF.
3. Participants who fulfill the diagnostic criteria of myelofibrosis including primary myelofibrosis and myelofibrosis arising from polycythemia vera and essential thrombocythemia
4. Life expectancy is greater than 6 months.
5. Subject has been receiving ruxolitinib therapy, is unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator; AND meeting the following criteria: receiving ruxolitinib \>3 months prior to enrollment; AND stable dose for 8 weeks before starting therapy with CK0804
6. Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of:
* presence of grade ≥2 anemia or thrombocytopenia or neutropenia, OR
* presence of disease-related symptoms, as determined by a Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN SAF TSS) score of ≥10 points, OR
* documented splenomegaly of at least 5 cm below the costal margin as measured by physical examination or splenomegaly as documented by ultrasound or MRI.
7. Willingness to avoid pregnancy or fathering children based on the criteria below
* Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last study treatment dose and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing should be communicated to the participants and their understanding confirmed.
* Women of childbearing potential must have a negative serum pregnancy test at screening before the first dose (within 3 days of the first study treatment dose) and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through the safety follow-up visit and must not donate oocytes during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed,
* Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.
8. ECOG performance status of 0 to 2
Exclusion Criteria
1. Any major surgery within 28 days before the first dose of study treatment.
2. Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
3. Received chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
4. Participant has received splenic irradiation within the past 6 months.
5. Significant concurrent, uncontrolled medical condition or infections, which in the opinion of the principal investigator may interfere in the study participation.
6. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
7. Women who are pregnant or breastfeeding.
8. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
9. Participants with laboratory values at screening as defined
* Platelets \< 50 × 10\^9/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions
* ANC \< 0.5 × 10\^9/L
* ALT ≥ 2.5 × ULN
* AST ≥ 2.5 × ULN
* Direct Bilirubin \> 2.0 × ULN
* ALP ≥ 3 × ULN
* Creatinine clearance \< 50 mL/min according to Cockcroft-Gault formula.
10. Unwillingness to be transfused with blood components including RBC and platelet transfusions.
11. Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.
2. Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
3. Received chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
4. Participant has received splenic irradiation within the past 6 months.
5. Significant concurrent, uncontrolled medical condition or infections, which in the opinion of the principal investigator may interfere in the study participation.
6. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
7. Women who are pregnant or breastfeeding.
8. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
9. Participants with laboratory values at screening as defined
* Platelets \< 50 × 10\^9/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions
* ANC \< 0.5 × 10\^9/L
* ALT ≥ 2.5 × ULN
* AST ≥ 2.5 × ULN
* Direct Bilirubin \> 2.0 × ULN
* ALP ≥ 3 × ULN
* Creatinine clearance \< 50 mL/min according to Cockcroft-Gault formula.
10. Unwillingness to be transfused with blood components including RBC and platelet transfusions.
11. Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cellenkos, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC Davis Health
Sacramento, California, United States
Site Status
RECRUITING
Columbia University
New York, New York, United States
Site Status
NOT_YET_RECRUITING
Montefiore Einstein Cancer Center
The Bronx, New York, United States
Site Status
RECRUITING
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Clinical Research Coordinator
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Abdelouahab H, Zhang Y, Wittner M, Oishi S, Fujii N, Besancenot R, Plo I, Ribrag V, Solary E, Vainchenker W, Barosi G, Louache F. CXCL12/CXCR4 pathway is activated by oncogenic JAK2 in a PI3K-dependent manner. Oncotarget. 2016 Jul 22;8(33):54082-54095. doi: 10.18632/oncotarget.10789. eCollection 2017 Aug 15.
Reference Type
BACKGROUND
Barbui T, Thiele J, Gisslinger H, Finazzi G, Vannucchi AM, Tefferi A. The 2016 revision of WHO classification of myeloproliferative neoplasms: Clinical and molecular advances. Blood Rev. 2016 Nov;30(6):453-459. doi: 10.1016/j.blre.2016.06.001. Epub 2016 Jun 11.
Reference Type
BACKGROUND
Barbui T, Thiele J, Gisslinger H, Kvasnicka HM, Vannucchi AM, Guglielmelli P, Orazi A, Tefferi A. The 2016 WHO classification and diagnostic criteria for myeloproliferative neoplasms: document summary and in-depth discussion. Blood Cancer J. 2018 Feb 9;8(2):15. doi: 10.1038/s41408-018-0054-y.
Reference Type
BACKGROUND
Barosi G, Mesa RA, Thiele J, Cervantes F, Campbell PJ, Verstovsek S, Dupriez B, Levine RL, Passamonti F, Gotlib J, Reilly JT, Vannucchi AM, Hanson CA, Solberg LA, Orazi A, Tefferi A; International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Proposed criteria for the diagnosis of post-polycythemia vera and post-essential thrombocythemia myelofibrosis: a consensus statement from the International Working Group for Myelofibrosis Research and Treatment. Leukemia. 2008 Feb;22(2):437-8. doi: 10.1038/sj.leu.2404914. Epub 2007 Aug 30. No abstract available.
Reference Type
BACKGROUND
Bogani C, Ponziani V, Guglielmelli P, Desterke C, Rosti V, Bosi A, Le Bousse-Kerdiles MC, Barosi G, Vannucchi AM; Myeloproliferative Disorders Research Consortium. Hypermethylation of CXCR4 promoter in CD34+ cells from patients with primary myelofibrosis. Stem Cells. 2008 Aug;26(8):1920-30. doi: 10.1634/stemcells.2008-0377. Epub 2008 May 29.
Reference Type
BACKGROUND
Brunstein CG, Miller JS, Cao Q, McKenna DH, Hippen KL, Curtsinger J, Defor T, Levine BL, June CH, Rubinstein P, McGlave PB, Blazar BR, Wagner JE. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics. Blood. 2011 Jan 20;117(3):1061-70. doi: 10.1182/blood-2010-07-293795. Epub 2010 Oct 15.
Reference Type
BACKGROUND
Brunstein CG, Miller JS, McKenna DH, Hippen KL, DeFor TE, Sumstad D, Curtsinger J, Verneris MR, MacMillan ML, Levine BL, Riley JL, June CH, Le C, Weisdorf DJ, McGlave PB, Blazar BR, Wagner JE. Umbilical cord blood-derived T regulatory cells to prevent GVHD: kinetics, toxicity profile, and clinical effect. Blood. 2016 Feb 25;127(8):1044-51. doi: 10.1182/blood-2015-06-653667. Epub 2015 Nov 12.
Reference Type
BACKGROUND
Cho SY, Xu M, Roboz J, Lu M, Mascarenhas J, Hoffman R. The effect of CXCL12 processing on CD34+ cell migration in myeloproliferative neoplasms. Cancer Res. 2010 Apr 15;70(8):3402-10. doi: 10.1158/0008-5472.CAN-09-3977. Epub 2010 Apr 13.
Reference Type
BACKGROUND
Emanuel RM, Dueck AC, Geyer HL, Kiladjian JJ, Slot S, Zweegman S, te Boekhorst PA, Commandeur S, Schouten HC, Sackmann F, Kerguelen Fuentes A, Hernandez-Maraver D, Pahl HL, Griesshammer M, Stegelmann F, Doehner K, Lehmann T, Bonatz K, Reiter A, Boyer F, Etienne G, Ianotto JC, Ranta D, Roy L, Cahn JY, Harrison CN, Radia D, Muxi P, Maldonado N, Besses C, Cervantes F, Johansson PL, Barbui T, Barosi G, Vannucchi AM, Passamonti F, Andreasson B, Ferrari ML, Rambaldi A, Samuelsson J, Birgegard G, Tefferi A, Mesa RA. Myeloproliferative neoplasm (MPN) symptom assessment form total symptom score: prospective international assessment of an abbreviated symptom burden scoring system among patients with MPNs. J Clin Oncol. 2012 Nov 20;30(33):4098-103. doi: 10.1200/JCO.2012.42.3863. Epub 2012 Oct 15.
Reference Type
BACKGROUND
Gladstone DE, Kim BS, Mooney K, Karaba AH, D'Alessio FR. Regulatory T Cells for Treating Patients With COVID-19 and Acute Respiratory Distress Syndrome: Two Case Reports. Ann Intern Med. 2020 Nov 17;173(10):852-853. doi: 10.7326/L20-0681. Epub 2020 Jul 6. No abstract available.
Reference Type
BACKGROUND
Gleitz HFE, Dugourd AJF, Leimkuhler NB, Snoeren IAM, Fuchs SNR, Menzel S, Ziegler S, Kroger N, Triviai I, Busche G, Kreipe H, Banjanin B, Pritchard JE, Hoogenboezem R, Bindels EM, Schumacher N, Rose-John S, Elf S, Saez-Rodriguez J, Kramann R, Schneider RK. Increased CXCL4 expression in hematopoietic cells links inflammation and progression of bone marrow fibrosis in MPN. Blood. 2020 Oct 29;136(18):2051-2064. doi: 10.1182/blood.2019004095.
Reference Type
BACKGROUND
Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi: 10.1056/NEJMoa1110556.
Reference Type
BACKGROUND
Hori S, Nomura T, Sakaguchi S. Control of regulatory T cell development by the transcription factor Foxp3. Science. 2003 Feb 14;299(5609):1057-61. doi: 10.1126/science.1079490. Epub 2003 Jan 9.
Reference Type
BACKGROUND
Kadia TM, Ma, H, Zeng K, Nishimoto M, Lyu Mi-Ae, Huang M, Yilmaz M, DiNardo DC, Issa GC, Parmar S, Iyer SP, Hari P, Daver NG, Jabbour E, Borthakur GM, and Verstovsek S. 2019. 'Phase I Clinical Trial of CK0801 (cord blood regulatory T cells) in Patients with Bone Marrow Failure Syndrome (BMF) Including Aplastic Anemia, Myelodysplasia and Myelofibrosis', Blood.
Reference Type
BACKGROUND
Kadia TM, Pemmaraju N, Yilmaz M, Li L, Lyu M, Huang M, Zeng K, Parmar S, DiNardo CD, Daver N, Issa GC, Jabbour E, Borthakur G, Verstovsek S. 2020. 'Adoptive Therapy with Allogeneic Cord Blood T Regulatory Cells Show Safety and Early Clinical Signal in Primary Myelofibrosis', Blood, 136: 41-42.
Reference Type
BACKGROUND
Kellner JN, Delemarre EM, Yvon E, Nierkens S, Boelens JJ, McNiece I, Olson A, Nieto Y, Ciurea S, Popat U, Ahmed S, Champlin R, Ramos J, Nishimoto M, Ma H, Ke Z, Thall P, Khoury JD, Negrin R, Andersson B, Parmar S. Third party, umbilical cord blood derived regulatory T-cells for prevention of graft versus host disease in allogeneic hematopoietic stem cell transplantation: feasibility, safety and immune reconstitution. Oncotarget. 2018 Nov 2;9(86):35611-35622. doi: 10.18632/oncotarget.26242. eCollection 2018 Nov 2.
Reference Type
BACKGROUND
Kotsianidis I, Bouchliou I, Nakou E, Spanoudakis E, Margaritis D, Christophoridou AV, Anastasiades A, Tsigalou C, Bourikas G, Karadimitris A, Tsatalas C. Kinetics, function and bone marrow trafficking of CD4+CD25+FOXP3+ regulatory T cells in myelodysplastic syndromes (MDS). Leukemia. 2009 Mar;23(3):510-8. doi: 10.1038/leu.2008.333. Epub 2008 Nov 20.
Reference Type
BACKGROUND
Lucca LE, Dominguez-Villar M. Modulation of regulatory T cell function and stability by co-inhibitory receptors. Nat Rev Immunol. 2020 Nov;20(11):680-693. doi: 10.1038/s41577-020-0296-3. Epub 2020 Apr 8.
Reference Type
BACKGROUND
Massa M, Campanelli R, Fois G, Villani L, Bonetti E, Catarsi P, Poletto V, Viarengo G, De Amici M, Rosti V, Gale RP, Barosi G. Reduced frequency of circulating CD4+CD25brightCD127lowFOXP3+ regulatory T cells in primary myelofibrosis. Blood. 2016 Sep 22;128(12):1660-2. doi: 10.1182/blood-2016-03-704577. Epub 2016 Aug 16. No abstract available.
Reference Type
BACKGROUND
Migliaccio AR, Adamson JW, Stevens CE, Dobrila NL, Carrier CM, Rubinstein P. Cell dose and speed of engraftment in placental/umbilical cord blood transplantation: graft progenitor cell content is a better predictor than nucleated cell quantity. Blood. 2000 Oct 15;96(8):2717-22.
Reference Type
BACKGROUND
Migliaccio AR, Martelli F, Verrucci M, Migliaccio G, Vannucchi AM, Ni H, Xu M, Jiang Y, Nakamoto B, Papayannopoulou T, Hoffman R. Altered SDF-1/CXCR4 axis in patients with primary myelofibrosis and in the Gata1 low mouse model of the disease. Exp Hematol. 2008 Feb;36(2):158-71. doi: 10.1016/j.exphem.2007.10.001.
Reference Type
BACKGROUND
Miwa Y, Hayashi T, Suzuki S, Abe S, Onishi I, Kirimura S, Kitagawa M, Kurata M. Up-regulated expression of CXCL12 in human spleens with extramedullary haematopoiesis. Pathology. 2013 Jun;45(4):408-16. doi: 10.1097/PAT.0b013e3283613dbf.
Reference Type
BACKGROUND
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
Reference Type
BACKGROUND
Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, Masszi T, Mishchenko E, Jourdan E, Vannucchi AM, Drummond MW, Jurgutis M, Kuliczkowski K, Gheorghita E, Passamonti F, Neumann F, Patki A, Gao G, Tefferi A. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug;1(5):643-51. doi: 10.1001/jamaoncol.2015.1590.
Reference Type
BACKGROUND
Rosti V, Massa M, Vannucchi AM, Bergamaschi G, Campanelli R, Pecci A, Viarengo G, Meli V, Marchetti M, Guglielmelli P, Bruno E, Xu M, Hoffman R, Barosi G; Italian Registry of Myelofibrosis with Myeloid Metaplasia; Myeloproliferative Disorders Research Consortium. The expression of CXCR4 is down-regulated on the CD34+ cells of patients with myelofibrosis with myeloid metaplasia. Blood Cells Mol Dis. 2007 May-Jun;38(3):280-6. doi: 10.1016/j.bcmd.2007.01.003. Epub 2007 Mar 9.
Reference Type
BACKGROUND
Song MK, Park BB, Uhm JE. Understanding Splenomegaly in Myelofibrosis: Association with Molecular Pathogenesis. Int J Mol Sci. 2018 Mar 18;19(3):898. doi: 10.3390/ijms19030898.
Reference Type
BACKGROUND
Storer BE. An evaluation of phase I clinical trial designs in the continuous dose-response setting. Stat Med. 2001 Aug 30;20(16):2399-408. doi: 10.1002/sim.903.
Reference Type
BACKGROUND
Tefferi A, Cervantes F, Mesa R, Passamonti F, Verstovsek S, Vannucchi AM, Gotlib J, Dupriez B, Pardanani A, Harrison C, Hoffman R, Gisslinger H, Kroger N, Thiele J, Barbui T, Barosi G. Revised response criteria for myelofibrosis: International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus report. Blood. 2013 Aug 22;122(8):1395-8. doi: 10.1182/blood-2013-03-488098. Epub 2013 Jul 9.
Reference Type
BACKGROUND
Tefferi A, Thiele J, Orazi A, Kvasnicka HM, Barbui T, Hanson CA, Barosi G, Verstovsek S, Birgegard G, Mesa R, Reilly JT, Gisslinger H, Vannucchi AM, Cervantes F, Finazzi G, Hoffman R, Gilliland DG, Bloomfield CD, Vardiman JW. Proposals and rationale for revision of the World Health Organization diagnostic criteria for polycythemia vera, essential thrombocythemia, and primary myelofibrosis: recommendations from an ad hoc international expert panel. Blood. 2007 Aug 15;110(4):1092-7. doi: 10.1182/blood-2007-04-083501. Epub 2007 May 8.
Reference Type
BACKGROUND
Tefferi A, Vaidya R, Caramazza D, Finke C, Lasho T, Pardanani A. Circulating interleukin (IL)-8, IL-2R, IL-12, and IL-15 levels are independently prognostic in primary myelofibrosis: a comprehensive cytokine profiling study. J Clin Oncol. 2011 Apr 1;29(10):1356-63. doi: 10.1200/JCO.2010.32.9490. Epub 2011 Feb 7.
Reference Type
BACKGROUND
Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. doi: 10.1056/NEJMoa1110557.
Reference Type
BACKGROUND
Wang JC, Sindhu H, Chen C, Kundra A, Kafeel MI, Wong C, Lichter S. Immune derangements in patients with myelofibrosis: the role of Treg, Th17, and sIL2Ralpha. PLoS One. 2015 Mar 20;10(3):e0116723. doi: 10.1371/journal.pone.0116723. eCollection 2015.
Reference Type
BACKGROUND
Yuan Y, Hess KR, Hilsenbeck SG, Gilbert MR. Bayesian Optimal Interval Design: A Simple and Well-Performing Design for Phase I Oncology Trials. Clin Cancer Res. 2016 Sep 1;22(17):4291-301. doi: 10.1158/1078-0432.CCR-16-0592. Epub 2016 Jul 12.
Reference Type
BACKGROUND
Zeng K, Ma H, Popat U, Nieto Y, Ciurea SO, Olson AL, Lyu M, Huang M, Nishimoto M, Qazilbash MH, Ramos JD, Shpall EJ, Champlin RE, Parmar S, Andersson BS. . 2019. 'Allogeneic Cord Blood Regulatory T Cells Can Prevent Graft Vs. Host Disease and Preserve Graft Vs Leukemia Effect: Update on Phase I/II Clinical Tria', Blood, 134.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CK0804.101.1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
NCT04279847
ACTIVE_NOT_RECRUITING
PHASE1
Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia
NCT00434239
UNKNOWN
EARLY_PHASE1
Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
NCT01340651
COMPLETED
PHASE2
Ruxolitinib in Patients With Myelofibrosis
NCT05762874
UNKNOWN
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
NCT03654768
ACTIVE_NOT_RECRUITING
PHASE2
Lenalidomide for Patients With Myelofibrosis (MF)
NCT00352794
COMPLETED
PHASE2
A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT02537613
ACTIVE_NOT_RECRUITING
PHASE1
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
NCT04562389
ACTIVE_NOT_RECRUITING
PHASE3
Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
NCT00022490
TERMINATED
PHASE2
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease
NCT02436135
TERMINATED
PHASE1
A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
NCT06773195
RECRUITING
PHASE1/PHASE2
Study of Regorafenib in Patients With Advanced Myeloid Malignancies
NCT03042689
COMPLETED
PHASE1
Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia
NCT00759603
COMPLETED
PHASE2
Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
NCT00593944
COMPLETED
PHASE1
A Study of APG-1252 in Patients With Myelofibrosis Who Progressed After Initial Therapy
NCT04354727
WITHDRAWN
PHASE1/PHASE2
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00096044
COMPLETED
PHASE2
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
NCT05447260
UNKNOWN
PHASE4
A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)(0457-009)(TERMINATED)
NCT00500006
TERMINATED
PHASE1
Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia
NCT02092324
COMPLETED
PHASE2
STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia
NCT00006052
COMPLETED
PHASE2
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib
NCT01776723
COMPLETED
PHASE1/PHASE2
Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
NCT00536341
COMPLETED
PHASE1/PHASE2
Ruxolitinib and Lenalidomide for Patients With Myelofibrosis
NCT01375140
COMPLETED
PHASE2
Ipilimumab in Treating Patients With Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT01757639
COMPLETED
PHASE1
Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms
NCT03878199
COMPLETED
PHASE1/PHASE2