Trial Title:
A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India
NCT ID:
NCT05891249
Condition:
Anemia
Conditions: Official terms:
Preleukemia
Anemia
Myelodysplastic Syndromes
Thalassemia
beta-Thalassemia
Luspatercept
Conditions: Keywords:
Luspatercept
ACE-536
Transfusion dependent
Beta-thalassemia
Myelodysplastic syndromes with ring sideroblasts
Anemia
Hemoglobinopathies
Hematologic diseases
Bone marrow diseases
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Luspatercept
Description:
Specified dose on specified days
Arm group label:
Luspatercept
Other name:
ACE-536
Other name:
REBLOZYL
Other name:
BMS-986346
Other name:
ROJUZDA
Summary:
The purpose of this study is to evaluate the safety and effectiveness of luspatercept in
participants who require regular blood cell transfusions due to b-thalassemia and
myelodysplastic syndromes in India
Criteria for eligibility:
Criteria:
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 prior
to 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 revised
International Prognostic Scoring System (IPSS-R) classification of very low, low, or
intermediate risk disease and the following criteria: i) RS ≥ 15% of erythroid
precursors in bone marrow. If the SF3B1 mutation is present, RS ≥ 5% will be
included.
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-macrophage
colony-stimulating factor (GM-CSF), both agents must have been discontinued ≥ 4
weeks prior to the date of enrollment.
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 prior
to enrollment.
- Use of chronic anticoagulant therapy is excluded unless the treatment stopped at
least 28 days prior to enrollment. Anticoagulant therapies used for prophylaxis for
surgery or high-risk procedures as well as low-molecular-weight (LMW) heparin for
superficial venous thrombosis and chronic aspirin are allowed.
- Cytotoxic agents or immunosuppressants or immunomodulatory drugs (IMiDs) ≤ 28 days
prior 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 chemical
injury or treatment with chemotherapy and/or radiation for other diseases.
- Participant has known clinically significant anemia due to iron, vitamin B12, or
folate deficiencies; autoimmune or hereditary hemolytic anemia; or gastrointestinal
bleeding.
- Iron deficiency to be determined by serum ferritin ≤ 15 micrograms per liter (μg/L)
and additional testing if clinically indicated (for example, calculated transferrin
saturation [iron/total iron binding capacity ≤ 20%] or bone marrow aspirate [BMA]
stain for iron).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Tulika Seth, Site 0001
Phone:
+911125432252
Facility:
Name:
Local Institution - 0011
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Withdrawn
Facility:
Name:
Vedanta Institute Of Medical Sciences
Address:
City:
Ahmedabad
Zip:
380009
Country:
India
Status:
Recruiting
Contact:
Last name:
Sandip A. Shah, Site 0002
Phone:
9824041170
Facility:
Name:
Local Institution - 0012
Address:
City:
Bengaluru
Zip:
560027
Country:
India
Status:
Withdrawn
Facility:
Name:
Local Institution - 0014
Address:
City:
Noida
Zip:
201303
Country:
India
Status:
Withdrawn
Facility:
Name:
Nilratan Sirkar Medical College and Hospital
Address:
City:
Kolkatta
Zip:
700014
Country:
India
Status:
Recruiting
Contact:
Last name:
Tuphan Dolai, Site 0007
Phone:
+919874890275
Facility:
Name:
Gauhati Medical College and Hospital
Address:
City:
Assam
Zip:
781032
Country:
India
Status:
Recruiting
Contact:
Last name:
Jina Bhattacharyya, Site 0005
Phone:
+919435557491
Facility:
Name:
HealthCare Global Enterprises Ltd. Hospital
Address:
City:
Bangalore
Zip:
560027
Country:
India
Status:
Recruiting
Contact:
Last name:
Nataraj K S, Site 0003
Phone:
9482141773
Facility:
Name:
Post Graduate Institute of Medical Education and Research
Address:
City:
Chandigarh
Zip:
160012
Country:
India
Status:
Recruiting
Contact:
Last name:
Pankaj Malhotra, Site 0004
Phone:
911722756680
Facility:
Name:
Rajiv Gandhi Cancer Institute And Research Centre
Address:
City:
Delhi
Zip:
110085
Country:
India
Status:
Recruiting
Contact:
Last name:
Dinesh Bhurani, Site 0010
Phone:
9971500861
Facility:
Name:
Local Institution - 0006
Address:
City:
Hyderabad
Zip:
500034
Country:
India
Status:
Recruiting
Contact:
Last name:
Site 0006
Facility:
Name:
Local Institution - 0009
Address:
City:
Kolkata
Zip:
700156
Country:
India
Status:
Withdrawn
Facility:
Name:
KEM Hospital and Seth G S Medical College
Address:
City:
Mumbai
Zip:
400012
Country:
India
Status:
Recruiting
Contact:
Last name:
S Chandrakala, Site 0008
Phone:
+919322042985
Start date:
June 5, 2023
Completion date:
April 13, 2026
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891249
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
