CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Cyclosporine +7 moredrug
Likely dose
Total body irradiation 600 cGy given in 3 fractionated doses of 200 cGy; conditioning with cyclosporine, methotrexate, and/or other immunosuppressive agents per protocolAI-extracted
Key inclusion· 8
  • ✓Cytologically proven myelodysplastic syndrome (RA, RA with ringed sideroblasts, RA with excess blasts, or CMML)
  • ✓IPSS score ≥0.5 OR red cell transfusion dependence (≥2 units/month for ≥6 months)
  • ✓HLA-matched donor available (related or unrelated; related 5/6 or 6/6 loci, unrelated at all loci or single mismatch)
  • ✓<20% blasts on bone marrow study within 1 month of study entry
Key exclusion· 4
  • ✕Prior myeloablative or nonmyeloablative allogeneic transplantation for MDS or AML
  • ✕Pregnant or nursing
  • ✕Active ongoing infection
  • ✕Other medical condition that would reduce life expectancy

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

Search/NCT00045305
NCT00045305Phase 2Completed
CompareCT.gov

A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes

Eastern Cooperative Oncology Group·interventional·Posted Jan 27, 2003·Updated Jun 28, 2023

In Brief

A Phase 2 clinical trial evaluating Cyclosporine, Methotrexate, and 6 other interventions for Leukemia and 2 related conditions. Completed, enrolled 17 participants across 6 sites.

Detailed Summary

RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartOct 24, 2006
Primary CompletionFeb 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 23.4 years ago

Interventions

Cyclosporinedrug

Immunosuppressant

Methotrexatedrug

Antimetabolite

Photopheresisdrug

Psoralens

Mycofenolate mofetildrug

an antibiotic with immunosuppressamt properties isolated from Penicillium spp

Pentostatindrug

Purine analogue

allogeneic bone marrowprocedure

Unmanipulated allogeneic bone marrow

peripheral blood stem cellprocedure

G-CSF mobilized peripheral blood stem cell

Total body irradiationradiation

a total of 600 cGy given in 3 200 cGy fractionated doses