BridgeMD
Tests treatment safety and results for Myelodysplastic Syndromes (MDS)
Official title A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
ClinicalTrials.gov ID: NCT04064060
What this study is testing
What is Luspatercept?
Luspatercept is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for myelodysplastic syndromes (mds).
Also referred to as ACE-536.
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
- A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase Transition Phase is defined as one Enrollment visit Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study.
- 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
- Participants must meet all the following criteria to be enrolled in this study:
- Participant is ≥ 18 years at the time of signing the informed consent form (ICF).
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant...
- Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive...
You likely can't join if
- The presence of any of the following will exclude a participant from enrollment:
- Applies to on treatment participants only- Concomitant use of any medications/procedures that are prohibited in the parent luspatercept protocol.
- Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.
- Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into...
- Applies to on treatment participants only- Pregnant or breastfeeding females.
- Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg...
See the full eligibility criteria
- Participants must meet all the following criteria to be enrolled in this study:
- Participant is ≥ 18 years at the time of signing the informed consent form (ICF).
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:
- Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR
- Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR
- Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments...
- Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.
- Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.
- Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral...
- Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies...
- Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84...
- The presence of any of the following will exclude a participant from enrollment:
- Applies to on treatment participants only- Concomitant use of any medications/procedures that are prohibited in the parent luspatercept protocol.
- Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.
- Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.
- Applies to on treatment participants only- Pregnant or breastfeeding females.
- Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from...
- Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Participant has any condition that confounds the ability to interpret data from the study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Oakland, California, United States
- Stanford, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- South Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Camperdown, Australia
- Brasschaat, Belgium
- Bruges, Belgium
- Ghent, Belgium
- Leuven, Belgium
+ 105 more site(s).
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; Oakland, California, United States; Stanford, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 119 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.