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New treatment option for Hematologic Malignancy
Official title An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
ClinicalTrials.gov ID: NCT06401356
What this study is testing
What is Pelabresib?
Pelabresib is an investigational medicine, being studied as a potential treatment for hematologic malignancy.
Also referred to as CPI-0610.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility for Ongoing Pelabresib Treatment
- Able to provide signed informed consent, agreeing to all protocol and ICF requirements.
- At least 18 years old and legally able to consent in the study's jurisdiction.
- Previously enrolled and currently receiving pelabresib in a parent study.
- Demonstrating clinical benefit from pelabresib, as judged by the investigator.
You likely can't join if
- Eligibility for Ongoing Pelabresib Treatment
- Legally institutionalized or under judicial protection.
- Enrolled in another treatment clinical trial (excluding the parent study).
- History of hypersensitivity to pelabresib, its excipients, or similar drugs.
- Significant gastrointestinal issues (e.g., active IBD, unresolved nausea/vomiting/diarrhea \> Grade 1) that may affect drug absorption.
- Any medical condition deemed unsuitable by the investigator.
See the full eligibility criteria
- Eligibility for Ongoing Pelabresib Treatment
- Able to provide signed informed consent, agreeing to all protocol and ICF requirements.
- At least 18 years old and legally able to consent in the study's jurisdiction.
- Previously enrolled and currently receiving pelabresib in a parent study.
- Demonstrating clinical benefit from pelabresib, as judged by the investigator.
- Willing and able to follow all study visits, treatments, and procedures.
- Agree to avoid pregnancy or fathering children:
- Men: Must use highly effective contraception (≥99% effective) and avoid sperm donation from eligibility check through 94 days post-treatment.
- Women of childbearing potential (WOCBP): Must test negative for pregnancy at eligibility, use highly effective contraception through 184 days post-treatment, undergo regular pregnancy testing, and avoid breastfeeding...
- Women not of childbearing potential (surgically sterile or postmenopausal ≥12 months without other cause) are eligible. Note: Women with amenorrhea due to chemo/radiotherapy are considered WOCBP and must use...
- Eligibility for Survival Follow-up
- Provide signed informed consent, agreeing to all protocol and ICF requirements.
- Are at least 18 years old and legally able to consent.
- Were previously enrolled in a pelabresib clinical study.
- Are willing and able to comply with follow-up procedures.
- Eligibility for Ongoing Pelabresib Treatment
- Legally institutionalized or under judicial protection.
- Enrolled in another treatment clinical trial (excluding the parent study).
- History of hypersensitivity to pelabresib, its excipients, or similar drugs.
- Significant gastrointestinal issues (e.g., active IBD, unresolved nausea/vomiting/diarrhea \> Grade 1) that may affect drug absorption.
- Any medical condition deemed unsuitable by the investigator.
- Uncontrolled illness or condition that may compromise safety or protocol compliance.
- Received systemic anticancer or investigational treatment (excluding parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose. (Hydroxyurea/anagrelide allowed up to 24 hours prior.)
- Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose.
- Used strong CYP3A4 inhibitors/inducers (e.g., St. John's wort) within 2 weeks before first dose. Use during treatment is prohibited.
- Female participants who are pregnant, breastfeeding, or not using required contraception.
- Male participants who do not agree to use contraception or refrain from sperm donation as specified.
- Unwilling or unable to comply with the study protocol.
- Eligibility for Survival Follow-up They are legally institutionalized or under judicial protection.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Antwerp, Belgium
- Bruges, Belgium
- Florence, FI, Italy
- Varese, VA, Italy
- Novara, Italy
- Amsterdam, Netherlands
- Cardiff, United Kingdom
- Glasgow, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Ann Arbor, Michigan, United States; New York, New York, United States; Antwerp, Belgium and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.