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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06113302
Other study ID # 2022-1080
Secondary ID NCI-2023-09312
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date June 2, 2026

Study information

Verified date March 2024
Source M.D. Anderson Cancer Center
Contact Guillermo Garcia-Manero, M D
Phone (713) 745-3428
Email ggarciam@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To learn if luspatercept is more effective in helping to reduce the number of blood transfusions needed by patients with LR-MDS.


Description:

Objectives: Primary Objectives: - To assess the clinical activity and safety of luspatercept in patients with transfusion independent lower risk MDS - To assess the clinical activity and safety of luspatercept in patients with transfusion dependent lower risk MDS - To study the effects on hematopoeisis of luspatercept in patients treated on this study Secondary Objectives: - To assess the duration of response of patients with treated with luspatercept in this study - To assess the overall survival and time to transformation of patients with treated with luspatercept in this study - To assess transfusion free survival period in patients that were transfusion independent treated with luspatercept in this study - To measure trends in neutrophil and platelet counts in patients treated in this study


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2, 2026
Est. primary completion date June 2, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years; as MDS there is no significant experience with luspatercept in pediatric patients 2. Cohorts #1 and #2: Diagnosis of MDS according to WHO 2023 criteria (5) and with low or int-1 risk by IPSS or a score of = 3.5 by IPSS-R.(3, 22) 3. Cohort #2: Patient defined as transfusion dependent by documentation of receiving at least 2 units of packed red blood cells (PRBCs) for a hemoglobin of less than 8.0 g/dL during an 8-week period prior to study enrollment. 4. Cohort #1: Patients with symptomatic anemia that are transfusion independent defined as not requiring a transfusion for a hemoglobin of less than 8.0 g/dL during an 8-week period prior to study enrollment. 5. MDS patients with either a platelet count of =100 K/uL and/or ANC of =1.8 K/uL 6. Patient must have signed an informed consent and is willing to participate in the study. 7. Adequate hepatic function with total bilirubin =3 x ULN, AST or ALT =3xULN. 8. Serum creatinine clearance =40mL/min and no end/stage renal disease (using Cockcroft-Gault). 9. ECOG performance status </=2. Exclusion Criteria: 1. Active infection not adequately responding to appropriate antibiotics. 2. Prior treatment with luspatercept or sotarcetept 3. Female patients who are pregnant or lactating. 4. Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study. Reproductive potential is defined as no previous surgical sterilization or females that are not post-menopausal for 12 months. 5. Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening. 6. History of an active malignancy within the past 2 years prior to study entry, with the exception of: a. Adequately treated in situ carcinoma of the cervix uteri b. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin or any other malignancy with a life expectancy of more than 2 years. 7. Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Luspatercept
Given by SC or (Injection)

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 through study completion; an average 1 year.
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