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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Erythrocyte Transfusion, Beta-Thalassemia
    Erythrocyte Transfusion, Beta-Thalassemia
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Luspatercept, Other: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief Summary

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia. The study is divided into the following periods: - Historical Period, - Screening/Run-in Period, - Double-blind Treatment Period (48 weeks), - Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks), - Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation - Post-treatment Follow-up Period

A Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib With Concomitant Luspatercept for Subjects With Anemia

  • Status Recruiting
    Recruiting
  • Condition Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
    Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: FEDRATINIB, Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: FEDRATINIB, Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Colorado Cancer Center, Aurora, Colorado, United States

Brief Summary

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib including a Sub-study with concomitant Luspatercept for subjects with anemia. The primary objective of the main study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib. The primary objective of the sub-study is to evaluate the safety and tolerability of Luspatercept when administered concomitantly with Fedratinib.

A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence

  • Status Recruiting
    Recruiting
  • Condition Primary Myelofibrosis, Anemia
    Primary Myelofibrosis, Anemia
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Mayo Clinic - Arizona, Phoenix, Arizona, United States

Brief Summary

This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

A Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

  • Status Recruiting
    Recruiting
  • Condition Myelodysplastic Syndromes (MDS), Beta-thalassemia, Myeloprolifera...
    Myelodysplastic Syndromes (MDS), Beta-thalassemia, Myeloprolifera...
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

UZ Leuven, Leuven, Belgium

Brief Summary

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following subjects: - Subjects 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 in the opinion of the investigator from continuing treatment with luspatercept. - Placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol). - Subjects 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 (unless they meet requirements as per parent protocol to cross-over to luspatercept treatment). The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Subjects 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 (Screening): up to 21 days prior to enrollment - Treatment Phase: For subjects 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. For placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol) will start at a luspatercept dose of 1.0 mg/kg every 3 weeks (Q3W). This does not apply to subjects that are in long-term follow-up from the parent protocol. - Follow-up Phase: - 42 Day Safety Follow-up Phase: subjects will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting. - Long-term Post-treatment Follow-up (LTPTFU) Phase: All subjects who are continuing in the LTPTFU Phase, will continue to be followed for 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. Subjects will be followed every 6 months until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Subjects will also be monitored for progression to AML or any malignancies/pre- malignancies. New anticancer or disease related therapies should be collected at the same time schedule. Subjects transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant subjects will discontinue from the study when all subjects fulfill 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. The shift to commercial drug is an alternative way to stop the study.

Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients

  • Status Not yet recruiting
    Not yet recruiting
  • Condition Myelodysplastic Syndromes
    Myelodysplastic Syndromes
  • Phase Phase 1 Phase 2
    Phase 1 Phase 2
INTERVENTION

Drug: Lenalidomide, Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Lenalidomide, Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Brief Summary

The purpose of this study is to evaluate if the combination of drugs, Lenalidomide and Luspatercept, will help improve the treatment of anemia in people with lower-risk MDS. Anemia is a condition in which the blood does not have enough healthy red blood cells. Red blood cells are made in an area of the bone called the bone marrow. Anemia is a common side effect in people who have MDS because this cancer disrupts the production of red blood cells in the bone marrow. Sometimes anemia can be treated successfully with a therapy known as an erythropoiesis-stimulating agent (ESA). The ESA medication tries to help the bone marrow make more red blood cells. However, some people do not respond to this treatment and have limited options. This research study is to improve anemia treatment options for people with MDS who have not responded, or are unlikely to respond to ESAs.

An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion

  • Status Recruiting
    Recruiting
  • Condition Myelodysplastic Syndromes
    Myelodysplastic Syndromes
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 20 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Chiba Aoba Municipal Hospital, Chiba, Japan

Brief Summary

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 2, multicenter, single-arm study to evaluate the efficacy, safety and Pharmacokinetics (PK) of luspatercept (ACE-536) for the treatment of anemia due to International prognostic scoring system-Revised (IPSS-R) very low, low or intermediate risk Myelodysplastic syndromes (MDS)in Japanese subjects who are not requiring Red blood cell (RBC) transfusion. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow up Period.

Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants Who Require Regular RBC Transfusions Due to Beta (β)-Thalassemia.

  • Status Recruiting
    Recruiting
  • Condition Beta-Thalassemia
    Beta-Thalassemia
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: ACE-536, Drug: ACE-536, Drug: ACE-536, Drug: ACE-536, Drug: ACE-536

Eligibility
  • Ages: 6 to 18 Years (Child, Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: ACE-536, Drug: ACE-536, Drug: ACE-536, Drug: ACE-536, Drug: ACE-536

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief Summary

This is a Phase 2a study to evaluate the safety and pharmacokinetics (PK) of luspatercept in pediatric participants who require regular red blood cell transfusions due to β-thalassemia. The study will be conducted in 2 parts: Part A will be in adolescent participants aged 12 to <18 years with two dose escalation cohorts of 6 participants each, followed by a dose expansion cohort of 30 participants. Part B will begin after a review of the safety in participants completing at least one year of treatment in Part A and will be in participants aged 6 to <12 with two dose escalation cohorts of 6 participants each. Upon completion of the Treatment Period, participants of any cohort who are benefiting from the study treatment, will be offered the opportunity to continue luspatercept treatment in the Long-term Treatment Period for up to 5 years from their first dose (Cycle 1 Day 1). Participants who discontinue study treatment any time will continue in the Posttreatment Follow-up Period for at least 5 years from their first dose of luspatercept (Cycle 1 Day 1), or 3 years from their last dose, whichever occurs later, or until they withdraw consent/assent, are lost to follow-up, or the End of Trial, whichever occurs first.

A Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions

  • Status Recruiting
    Recruiting
  • Condition Myelodysplastic Syndromes
    Myelodysplastic Syndromes
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 20 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Peking Union Medical College Hospital, Beijing, China

Brief Summary

This is a Phase 2, multicenter, single-arm bridging study to evaluate the efficacy, pharmacokinetics, and safety of luspatercept (ACE-536) for the treatment of anemia due to IPSSR very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese subjects with ring sideroblasts who require RBC transfusions. The study is divided into the Screening Period, Treatment Period (Primary Phase and Extension Phase) and a Posttreatment Follow-up Period and will enroll a total of 30 subjects.

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Thalassemia
    Thalassemia
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Luspatercept, Other: Placebo, Other: Best Supportive Care (BSC)

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept, Other: Placebo, Other: Best Supportive Care (BSC)

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief Summary

This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP) and Post-Treatment Follow-up Period (PTFP). It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus placebo.

Efficacy and Safety Study of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions

  • Status Recruiting
    Recruiting
  • Condition Myelodysplastic Syndromes
    Myelodysplastic Syndromes
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: Luspatercept, Drug: Epoetin alfa

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Luspatercept, Drug: Epoetin alfa

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Alabama Oncology - Grandview Cancer Center, Birmingham, Alabama, United States

Brief Summary

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is an interventional active-controlled, open-label, randomized Phase 3 study to compare the efficacy and safety of luspatercept (ACE-536) versus epoetin alfa for the treatment of anemia due to IPSS-R very low, low or intermediate risk MDS in ESA naïve subjects who require RBC transfusions. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow-up Period.