To hear about similar clinical trials, please enter your email below
Trial Title:
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
NCT ID:
NCT06113302
Condition:
Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Luspatercept
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Luspatercept
Description:
Given by SC or (Injection)
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Other name:
ACE-536
Summary:
To learn if luspatercept is more effective in helping to reduce the number of blood
transfusions needed by patients with LR-MDS.
Detailed 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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Guillermo Garcia-Manero, M D
Phone:
713-745-3428
Email:
ggarciam@mdanderson.org
Investigator:
Last name:
Guillermo Garcia-Manero, M D
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
June 2, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06113302
http://www.mdanderson.org
