Phase
Condition
Anemia
Myelodysplastic Syndromes (Mds)
Thalassemia
Treatment
Luspatercept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
β-Thalassemia Cohort
Documented diagnosis of β-thalassemia or hemoglobin (Hb E/β-thalassemia). (β-thalassemia with mutation and/or multiplication of alpha [α] globin is allowed).
Regularly transfused, defined as 6 RBC units to 20 RBC units in the 24 weeks priorto enrollment and no transfusion-free period for > 35 days during that period.
MDS-RS Cohort
- Participant has documented diagnosis of MDS according to World Health Organization (WHO) (2016)/French-American-British FAB classification that meets revisedInternational Prognostic Scoring System (IPSS-R) classification of very low, low, orintermediate risk disease and the following criteria: i) RS ≥ 15% of erythroidprecursors in bone marrow. If the SF3B1 mutation is present, RS ≥ 5% will beincluded.
ii) Less than 5% blasts in bone marrow and < 1% peripheral blood blasts. iii) Peripheral blood white blood cell (WBC) count < 13,000/ microliters (μL).
- If the participant was previously treated with erythropoiesis-stimulating agents (ESAs) or granulocyte colony-stimulating factor (G-CSF)/granulocyte-macrophagecolony-stimulating factor (GM-CSF), both agents must have been discontinued ≥ 4weeks prior to the date of enrollment.
Exclusion
Exclusion Criteria:
β-Thalassemia Cohort
A diagnosis of Hb S/β-thalassemia or α-thalassemia (for exampe, Hemoglobin H).
Deep vein thrombosis (DVT) or stroke requiring medical intervention ≤ 24 weeks priorto enrollment.
Use of chronic anticoagulant therapy is excluded unless the treatment stopped atleast 28 days prior to enrollment. Anticoagulant therapies used for prophylaxis forsurgery or high-risk procedures as well as low-molecular-weight (LMW) heparin forsuperficial venous thrombosis and chronic aspirin are allowed.
Cytotoxic agents or immunosuppressants or immunomodulatory drugs (IMiDs) ≤ 28 daysprior to enrollment (ie, antithymocite globulin or cyclosporine or thalidomide).
MDS-RS Cohort
MDS associated with del 5q cytogenetic abnormality.
Secondary MDS, that is, MDS that is known to have arisen as the result of chemicalinjury or treatment with chemotherapy and/or radiation for other diseases.
Participant has known clinically significant anemia due to iron, vitamin B12, orfolate deficiencies; autoimmune or hereditary hemolytic anemia; or gastrointestinalbleeding.
Iron deficiency to be determined by serum ferritin ≤ 15 micrograms per liter (μg/L)and additional testing if clinically indicated (for example, calculated transferrinsaturation [iron/total iron binding capacity ≤ 20%] or bone marrow aspirate [BMA]stain for iron).
Study Design
Connect with a study center
All India Institute of Medical Sciences
New Delhi, Delhi 110029
IndiaActive - Recruiting
Local Institution - 0001
New Delhi, Delhi 110029
IndiaSite Not Available
Local Institution - 0011
New Delhi, Delhi 110029
IndiaSite Not Available
Local Institution - 0002
Ahmedabad, Gujarat 380009
IndiaActive - Recruiting
Vedanta Institute Of Medical Sciences
Ahmedabad, Gujarat 380009
IndiaActive - Recruiting
Local Institution - 0012
Bengaluru, Karnataka 560027
IndiaSite Not Available
Local Institution - 0014
Noida, Uttar Pradesh 201303
IndiaSite Not Available
Local Institution - 0007
Kolkatta, West Bangal 700014
IndiaActive - Recruiting
Nilratan Sirkar Medical College and Hospital
Kolkatta, West Bangal 700014
IndiaActive - Recruiting
Gauhati Medical College and Hospital
Assam, 781032
IndiaActive - Recruiting
Local Institution - 0005
Assam, 781032
IndiaActive - Recruiting
HealthCare Global Enterprises Ltd. Hospital
Bangalore, 560027
IndiaActive - Recruiting
Local Institution - 0003
Bangalore, 560027
IndiaActive - Recruiting
Local Institution - 0004
Chandigarh, 160012
IndiaSite Not Available
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
IndiaActive - Recruiting
Local Institution - 0010
Delhi, 110085
IndiaActive - Recruiting
Rajiv Gandhi Cancer Institute And Research Centre
Delhi, 110085
IndiaActive - Recruiting
Local Institution - 0006
Hyderabad, 500034
IndiaCompleted
Local Institution - 0009
Kolkata, 700156
IndiaSite Not Available
KEM Hospital and Seth G S Medical College
Mumbai, 400012
IndiaActive - Recruiting
Local Institution - 0008
Mumbai, 400012
IndiaActive - Recruiting
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