NCT05178342

Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes With CA-4948

A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anemia in LR-MDS patients

Detailed description

Anemia in non-transfusion dependent (NTD) or transfusion dependent (low or high transfusion burden, LTB/HTB) patients with very low, low or intermediate risk myelodysplastic syndromes

Conditions

• Myelodysplastic Syndromes
• Anemia

Interventions

Type	Name	Description
DRUG	CA-4948	Patients will be treated orally with CA-4948 at 300 mg BID (2x200mg) over 4 cycles. One cycle consists of 28 days, 21 of which are treatment days, followed by 7 days off. Patients with erythroid response (HI-E) after 4 cycles who tolerate CA-4948 may continue to receive CA-4948 until loss of HI-E response.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-01-05
• Last updated: 2024-08-13

Locations

15 sites across 1 country: Germany