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Be Part of Research - Trial Details - A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies
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A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

Completed

Open to: ALL

Age: 18.0 - N/A

Belfast Cardiff Cambridge Manchester Headington London London Glasgow

Medical Conditions

Myelofibrosis
Leukemia, Myelocytic, Acute
Myelodysplastic/Myeloproliferative Neoplasm
Myelodysplastic Syndrome (MDS)
Preleukemia
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Disease
Hematological Disease
Precancerous Conditions
Neoplasms
Leukemia
Neoplasms by Histologic Type
Essential Thrombocytosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Phase 1 Part: Open-label, sequential dose escalation study of pelabresib (CPI-0610) in patients with previously treated Acute Leukemia, Myelodysplastic/Myeloproliferative Neoplasms, and Phase 2 Part: Open-label study of pelabresib (CPI-0610) with and without Ruxolitinib in patients with Myeloproliferative Neoplasms (Myelofibrosis and Essential Thrombocythemia).

Pelabresib (CPI-0610) is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2014 Jan 2025

Publications

"Stein EM, Fathi AT, Harb WA, Colak G, Fusco A, Mangan JK. Results from phase 1 of the MANIFEST clinical trial to evaluate the safety and tolerability of pelabresib in patients with myeloid malignancies. Leuk Lymphoma. 2024 Apr;65(4):503-510. doi: 10.1080/10428194.2023.2300710. Epub 2024 Jan 23."; "38259250"; "Gupta V, Mascarenhas J, Kremyanskaya M, Rampal RK, Talpaz M, Kiladjian JJ, Vannucchi AM, Verstovsek S, Colak G, Dey D, Harrison C. Matching-adjusted indirect comparison of the pelabresib-ruxolitinib combination vs JAKi monotherapy in myelofibrosis. Blood Adv. 2023 Sep 26;7(18):5421-5432. doi: 10.1182/bloodadvances.2023010628."; "37530627"; "Mascarenhas J, Kremyanskaya M, Patriarca A, Palandri F, Devos T, Passamonti F, Rampal RK, Mead AJ, Hobbs G, Scandura JM, Talpaz M, Granacher N, Somervaille TCP, Hoffman R, Wondergem MJ, Salama ME, Colak G, Cui J, Kiladjian JJ, Vannucchi AM, Verstovsek S, Curto-Garcia N, Harrison C, Gupta V. MANIFEST: Pelabresib in Combination With Ruxolitinib for Janus Kinase Inhibitor Treatment-Naive Myelofibrosis. J Clin Oncol. 2023 Nov 10;41(32):4993-5004. doi: 10.1200/JCO.22.01972. Epub 2023 Mar 7."; "36881782"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : CPI-0610 is administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)

Intervention Arm Group : Phase 1;Phase 2 (Arm 1): Prior JAKi Monotherapy Arm (MF patients treated with pelabresib alone);Phase 2 (Arm 2): Prior JAKi Combination Arm;Phase 2 (Arm 3): JAKi Naïve Combination Arm;Phase 2 (Arm 4): Essential Thrombocythemia (ET) Monotherapy Arm;

Intervention Type : DRUG
Intervention Description : Ruxolitinib is given orally, twice daily (BID), on a continuous basis for 21 consecutive days of each 21-day cycle.

Intervention Arm Group : Phase 2 (Arm 2): Prior JAKi Combination Arm;Phase 2 (Arm 3): JAKi Naïve Combination Arm;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Belfast City Hospital
    Belfast
    BT9 7AB
  • University Hospital of Wales
    Cardiff
    CF14 4XW
  • University of Cambridge
    Cambridge
    CB2 0QQ
  • The Christie Hospital
    Manchester
    M20 4BX
  • Oxford University Hospitals
    Headington
    Oxford
    OX3 7LE
  • University College London Hospital's NHS foundation Trust
    London
    NW1 2PG
  • Guys and St Thomas' Hospital - Haematology
    London
    SE1 9RT
  • Beatson West of Scotland Cancer Centre
    Glasgow
    G12 0YN


The study is sponsored by Constellation Pharmaceuticals and is in collaboration with The Leukemia and Lymphoma Society.



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Read full details for Trial ID: NCT02158858
Last updated 06 October 2025

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