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Clinical Trial 19872

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03682536

Phase: Phase III
Principal Investigator: Komrokji, Rami

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Overview

Study Title

A Phase 3, Open-Label, Randomized 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 Myelodysplastic Syndromes (Mds) In Esa Naïve Subjects Who Require Red Blood Cell Transfusions The Commands Trial

Summary

This clinical research study is of an investigational drug, called luspatercept, which is being developed to treat a number of different conditions, including anemia, as a result of MDS.

Objective

Primary objective: To evaluate the efficacy of luspatercept on RBC transfusion independence (RBC-TI) compared to 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

Treatments

Therapies

Therapy (NOS)

Medications

ACE-536 (Luspatercept); Epoetin Alfa (erythropoietin); Luspatercept (); Not Applicable ()

Inclusion Criteria

  • 18 years of age or older
  • Willing and able to adhere to the study visit schedule and other protocol requirements.
  • Has a documented diagnosis of MDS according to WHO 2016 classification that meets IPSS-R classification of very low, low, or intermediate risk disease, and: > Has an endogenous serum erythropoietin (sEPO) level of > Requires RBC transfusions, per protocol.
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
  • Females of childbearing potential (FCBP), as defined per protocol, must: (a) Have two negative pregnancy tests as verified by the investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of W1D1). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. (b) If sexually active, agree to use, and be able to comply with, highly effective contraception without interruption, 5 weeks prior to starting investigational product, during the study therapy (including dose interruptions), and for 12 weeks after discontinuation of study therapy.
  • Male participants must: Practice true abstinence (which must be reviewed prior to each IP administration or on a monthly basis [eg, in the event of dose delays]) or agree to use a condom (latex or non-latex, but not made out of natural [animal] membrane) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 12 weeks following investigational product discontinuation, even if he has undergone a successful vasectomy.

    • Exclusion Criteria

  • Participant with the any of the following prior treatments: (a) Erythropoiesis-stimulating agents (ESAs) (b) Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for treatment of febrile neutropenia (c) Disease modifying agents (eg, immune-modulatory drug [IMiDs such as lenalidomide] Except if the participant received ≤ 1 week of treatment with a disease modifying agent ≥ 8 weeks from randomization, at the investigator's discretion. (d) Hypomethylating agents -Participants may be randomized at the investigator's discretion contingent that the participant received no more than 2 doses of HMA. The last dose must be ≥ 8 weeks from the date of randomization. (e) Luspatercept (ACE-536) or sotatercept (ACE-011) (f) Immunosuppressive therapy for MDS (g)Hematopoietic cell transplant
  • Participant with MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable (MDS-U) according to WHO 2016 classification.
  • Participant with myelodysplastic/myeloproliferative neoplasms (MDS/MPN) according to WHO 2016 classification (ie, Chronic myelomonocytic leukemia (CMML), Atypical chronic myeloid leukemia (aCML), BCR-ABL12, Juvenile myelomonocytic leukemia (JMML), MDS/MPN with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T), MDS/MPN unclassifiable.
  • Participant with secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases.
  • Participant with known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration. Participant with drug induced anemia (eg, mycophenolate).
  • Iron deficiency to be determined by serum ferritin > Participant with known history of diagnosis of AML.
  • Participant receiving any of the following treatment within 8 weeks prior to randomization: Anticancer cytotoxic chemotherapeutic agent or treatment, Systemic corticosteroid, except for participants on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS, Iron-chelating agents, except for participants on a stable or decreasing dose for at least 8 weeks prior to randomization, Other RBC hematopoietic growth factors (eg, Interleukin-3), Androgens, unless to treat hypogonadism, Hydroxyurea, Oral retinoids (except for topical retinoids), Arsenic trioxide, Interferon and interleukins, Investigational drug or device, or approved therapy for investigational use (if 5 times the half-life of the previous investigational drug exceeds 8 weeks, then the time of exclusion should be extended up to 5 times the half-life of the investigational drug)
  • Participant with uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment.
  • Participant with laboratory abnormalities as outlined per protocol.
  • Participant with prior history of malignancies, other than MDS, unless the participant has been free of the disease for ≥ 5 years. However, participants with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system).
  • Other exclusions apply

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