Loading clinical trials...

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myeloproliferative Neoplasms)

NCT02158858•Constellation Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* Age: Adults ≥18 years.
•* Diagnosis: Histologically or cytologically confirmed diagnosis of one of the following hematologic malignancies:
•* Acute myelogenous leukemia (AML)
•* Acute lymphocytic leukemia (ALL)
•* Acute undifferentiated or biphenotypic leukemia
•* Chronic myeloid leukemia (CML) in blast crisis
•* Myelodysplastic syndrome (MDS)
•* Myelodysplastic/myeloproliferative neoplasms (MDS/MPN)
•* Myelofibrosis (MF)
•* Performance Status: ECOG ≤2.
+50 more criteria

Exclusion Criteria

•* Untreated newly diagnosed acute leukemia (unless AML with myelodysplasia-related changes and 20-30% blasts)
•* Relapsed/refractory acute leukemia where further induction chemotherapy is beneficial
•* Acute leukemia relapse \<6 months after allogeneic SCT
•* CML in blast crisis treated with only one TKI
•* Very low/low risk MDS without prior treatment
•* CNS involvement by leukemia (unless resolved)
•* Active HIV, Hepatitis B or C infection
•* GI impairment affecting absorption (unresolved nausea, vomiting, diarrhea \>CTCAE grade 1)
•* Significant cardiac disease (recent MI/angina, high cTn, QTcF \>470 ms, LVEF \<50%, uncontrolled arrhythmia, etc.)
•* Severe/uncontrolled comorbidities
+29 more criteria

Locations (48)

Mayo Clinic Arizona

Phoenix, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern University - Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Washington University School of Medicne Neuromuscular Division Department of Neurology Research

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

ICAHN School of Medicine at Mount Sinai

New York, New York, United States

Weill Medical College and New York Presbyterian Hospital

New York, New York, United States

Key Dates

Start Date

July 16, 2014

Primary Completion Date

January 9, 2025

Completion Date

January 9, 2025

Last Updated

October 8, 2025

Enrollment

336

ACTUAL participants

Conditions

MyelofibrosisLeukemia, Myelocytic, AcuteMyelodysplastic/Myeloproliferative NeoplasmMyelodysplastic Syndrome (MDS)PreleukemiaPrimary MyelofibrosisMyeloproliferative DisordersBone Marrow DiseaseHematological DiseasePrecancerous ConditionsNeoplasmsLeukemiaNeoplasms by Histologic TypeEssential Thrombocytosis

Interventions

Pelabresib

DRUG

Ruxolitinib

DRUG

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

View study

RECRUITINGPHASE1

Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

NCT07270978

Acute Myeloid LeukemiaMyelodysplastic Syndromes+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms

Momelotinib During and After HCT in Myelofibrosis