CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 303 enrolled
Drug / intervention
Cyclosporine +4 moredrug
Likely dose
Total Lymphoid Irradiation 8 Gy total (0.8 Gy/day from days -11 to -7 and days -4 to -2, plus 2 additional 0.8 Gy fractions on day -1); Anti-thymocyte globulin 7.5 mg/kg IV over days -11 to -7; Cyclosporine 5 mg/kg orally twice daily starting day -3; Mycophenolate mofetil 15 mg/kg starting day 0 (twice daily for related donor, three times daily for unrelated donor)AI-extracted
Key inclusion· 4
  • ✓Diagnosis of one of several specific hematolymphoid malignancies warranting allogeneic HST, including indolent advanced-stage NHL, mantle cell lymphoma, CLL, Hodgkin lymphoma, acute leukemias in complete remission, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or myelodysplastic/myeloproliferative syndromes
  • ✓Age >50 years OR age <50 with high risk for regimen-related toxicity from myeloablative transplants due to pre-existing medical conditions or prior therapy
  • ✓HLA-identical sibling or matched unrelated donor available (one antigen-mismatched donors allowed after discussion with transplant team and PI)
  • ✓Able to provide informed consent
Key exclusion· 10
  • ✕Progressive disease despite conventional therapies or acute leukemias not in complete remission
  • ✕Uncontrolled CNS involvement with disease
  • ✕Cardiac ejection fraction <30%
  • ✕Uncontrolled cardiac failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00185640
NCT00185640Phase 2Completed
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Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

Stanford University·interventional·Posted Sep 16, 2005·Updated Jun 29, 2021

In Brief

A Phase 2 clinical trial evaluating Cyclosporine, Anti-thymocyte globulin (ATG), and 3 other interventions for Blood Cancer and Leukemia. Completed, enrolled 303 participants across 1 site.

Detailed Summary

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Cancer, Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartMar 1, 2003
Primary CompletionApr 1, 2014
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 20.8 years ago

Interventions

Cyclosporinedrug

Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL

Anti-thymocyte globulin (ATG)drug

1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT

Mycophenolate mofetil (MMF)drug

Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.

Filgrastimdrug

* Donors mobilized with 16 µg/kg/day filgrastim. * As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day

Total Lymphoid Irradiation (TLI)radiation

0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.