CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Reduced intensity conditioning +2 moreprocedure
Likely dose
Prophylactic donor leukocyte infusion: 5 × 10^7 CD3+ cells/kg recipient weight if GVHD grade 0-1 overall or skin grade 1 on day +100AI-extracted
Key inclusion· 8
  • ✓Age ≥55 years with hematological malignancy considered appropriate for allogeneic transplant
  • ✓Any age with hematologic malignancy ineligible for conventional myeloablative transplant due to organ dysfunction
  • ✓Any age with relapsed or refractory disease following prior autologous or allogeneic transplant
  • ✓Multiple myeloma refractory to or failing conventional chemotherapy (VAD, pulse decadron, alkylating agents) OR with poor-prognosis chromosomal abnormality
Key exclusion· 4
  • ✕Acute leukemia
  • ✕HIV positive status
  • ✕Pregnant
  • ✕Any physical or psychological condition posing unacceptable risk per investigator judgment

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

Search/NCT00143845
NCT00143845Phase 2Completed
CompareCT.gov

Phase II Trial of Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Reduced Intensity Allogeneic Stem Cell Transplantation

University of Michigan Rogel Cancer Center·interventional·Posted Sep 2, 2005·Updated Mar 8, 2017

In Brief

A Phase 2 clinical trial evaluating Reduced intensity conditioning, Rapid immunosuppressive taper, and 1 other intervention for Multiple Myeloma and 2 related conditions. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma, Lymphocytic Leukemia, Chronic, Lymphoma, Low-Grade
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartApr 1, 2003
Primary CompletionNov 1, 2010
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 20.8 years ago

Interventions

Reduced intensity conditioningprocedure

Busulfan and Fludarabine regimen

Rapid immunosuppressive taperprocedure

Taper of Tacrolimus, Methotrexate and Mycophenolate Mofetil

Prophylactic donor leukocyte infusionsprocedure

If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.