CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Thymoglobulin +5 moredrug
Likely dose
Thymoglobulin 0.5 mg/kgfrom 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.

Search/NCT02833805
NCT02833805Phase 2Completed

A Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic Anemia

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jul 14, 2016·Updated Jul 12, 2022

In Brief

A Phase 2 clinical trial evaluating Thymoglobulin, Fludarabine, and 4 other interventions for Severe Aplastic Anemia and 3 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 14, 2016
Enrollment StartSep 1, 2016
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.0 years ago

Interventions

Thymoglobulindrug

Day -9: 0.5 mg/kg Days -8 and -7: 2 mg/kg daily

Fludarabinedrug

Days -6 through -2: 30 mg/m\^2 IV daily

Cyclophosphamidedrug

Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily

Total body irradiationradiation

Day -1: 200 centigray (cGy) in a single fraction

Tacrolimusdrug

Start on Day 5 through Day 365

Mycophenolate mofetildrug

Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)