CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Therapeutic Allogeneic Lymphocytesbiological
Likely dose
Therapeutic Allogeneic Lymphocytes given IV (specific cell dose/volume not stated in published record)AI-extracted
Key inclusion· 5
  • ✓Prior nonmyeloablative allogeneic transplantation with fludarabine/2 Gy TBI, 4 Gy TBI, or 2–4 Gy TBI conditioning from related or unrelated donor
  • ✓Persistent, relapsed, or progressing malignancy after nonmyeloablative allogeneic transplantation
  • ✓Ability to tolerate steroid taper to ≤0.25 mg/kg/day; all other immunosuppressive therapy discontinued ≥2 weeks without significant GVHD flare
  • ✓Persistent donor CD3 cells >5% by DNA-based assay (ampFLP, FISH, or VNTR)
Key exclusion· 5
  • ✕Grade II–IV acute GVHD or extensive chronic GVHD
  • ✕Karnofsky score <50% (or Lansky Play-Performance Score <40 for pediatric patients)
  • ✕Donor not suitable for apheresis per AABB criteria or institutional guidelines
  • ✕Donor pregnancy, HIV, or HTLV infection

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

Search/NCT00068718
NCT00068718Phase 2Completed
CompareCT.gov

Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-center Trial

Fred Hutchinson Cancer Center·interventional·Posted Sep 11, 2003·Updated Jan 31, 2020

In Brief

A Phase 2 clinical trial evaluating Therapeutic Allogeneic Lymphocytes for Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 5 related conditions. Completed, enrolled 35 participants across 4 sites in 3 countries.

Detailed Summary

This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed (disease that has returned), or progressing cancer after donor hematopoietic cell transplantation. White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back (recurrent) after a donor hematopoietic cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma
CountriesGermany, Italy, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartMay 1, 2003
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 22.8 years ago

Interventions

Therapeutic Allogeneic Lymphocytesbiological

Given IV