At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 enrolled
Drug / intervention
Abataceptdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Tolerability Trial of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor Hematopoietic Stem Cell Transplant
In Brief
A Phase 2 clinical trial evaluating Abatacept for AML and 11 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed Summary
The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAML, ALL, Undifferentiated Leukemia, Biphenotypic Leukemia, Refractory Anemia, Refractory Anemia With Ringed Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia, Ref. Cytopenia w Multilineage Dysplasia & Ringed Sideroblasts, Refractory Anemia With Excess Blasts-1 (5-10% Blasts), Refractory Anemia With Excess Blasts-2 (10-20% Blasts), Myelodysplastic Syndrome, Unclassified, MDS Associated With Isolated Del (5q)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionNov 2012
Study CompletionJan 2013
TodayJul 2026
First PostedNov 13, 2009
Enrollment StartNov 1, 2009
Primary CompletionNov 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.6 years ago
Interventions
Abataceptdrug
Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.