CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
anti-thymocyte globulin +11 morebiological
Likely dose
Not stated in record
Key inclusion· 13
  • Diagnosis of severe aplastic anemia that failed at least 1 course of standard immunosuppressive regimen with cyclosporine and anti-thymocyte globulin
  • Acute leukemia (AML with antecedent MDS, secondary AML, or high-risk cytogenetics; or ALL with high-risk cytogenetics) with resistant/recurrent disease after combination chemotherapy or in first remission at high risk of relapse
  • Chronic myelogenous leukemia in chronic phase (failed imatinib, failed interferon after 6+ months, or intolerant to interferon) or accelerated phase with <20% blasts
  • Myeloproliferative and myelodysplastic syndromes including myelofibrosis (after splenectomy), refractory anemia, refractory anemia with excess blasts, or chronic myelomonocytic leukemia
Key exclusion· 8
  • Uncontrolled CNS disease for hematologic malignancies
  • Syngeneic donors not permitted
  • HIV antibody positive
  • Active serious infection

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

Search/NCT00053989
NCT00053989Phase 2Completed

Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders

Roswell Park Cancer Institute·interventional·Posted Feb 6, 2003·Updated Feb 10, 2020

In Brief

A Phase 2 clinical trial evaluating anti-thymocyte globulin, graft-versus-tumor induction therapy, and 10 other interventions for Chronic Myeloproliferative Disorders and 7 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops 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). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.

Study Details

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2003
Enrollment StartJan 29, 2002
Primary CompletionJul 19, 2018
TodayJul 2, 2026
Enrollment to primary: 16.5 yearsPosted 23.4 years ago

Interventions

anti-thymocyte globulinbiological

iv

graft-versus-tumor induction therapybiological

iv

sargramostimbiological

iv

therapeutic allogeneic lymphocytesbiological

iv

cyclophosphamidedrug

injection

fludarabine phosphatedrug

iv

methylprednisolonedrug

oral

mycophenolate mofetildrug

oral

tacrolimusdrug

oral

allogeneic bone marrow transplantationprocedure

iv

peripheral blood stem cell transplantationprocedure

iv

umbilical cord blood transplantationprocedure

iv