CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Rituxan +8 moredrug
Likely dose
Melphalan 140 mg/m² IV on Day -8; Thiotepa 5 mg/kg IV on Day -7; Fludarabine 40 mg/m² IV Days -6 to -3; Cyclophosphamide 50 mg/kg IV on Day -6; TBI 2 Gy on Day -1; Rituxan 375 mg/m² IV on Day -9 (for CD20+ malignancies)AI-extracted
Key inclusion· 8
  • ✓One of the following hematologic malignancies: AML, MDS, ALL, CML, NHL, HD, CLL, or chronic eosinophilic leukemia
  • ✓Two CB units available, matched at 4, 5, or 6/6 HLA class I and II antigens, each with ≥1E7 total nucleated cells/kg recipient body weight
  • ✓Karnofsky performance score ≥60% (age ≥12 years) or Lansky scale (age <12 years) for myeloablative regimens; ECOG PS <3 or Karnofsky ≥60% for non-myeloablative
  • ✓Age >1 month and ≤60 years for myeloablative therapy (Regimen 1); ≤80 years for non-myeloablative (Regimen 2); ≤50 years for VP16-TBI (Regimen 3)
Key exclusion· 5
  • ✕HIV positive
  • ✕Pregnancy
  • ✕Serious medical condition
  • ✕Malignant cells in CSF (positive lumbar puncture) or documented metastatic parenchymal disease

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

Search/NCT00067002
NCT00067002Phase 2Completed
CompareCT.gov

Randomized Trial of Unmanipulated Versus Expanded Cord Blood

M.D. Anderson Cancer Center·interventional·Posted Aug 11, 2003·Updated May 1, 2019

In Brief

A Phase 2 clinical trial evaluating Expanded allogeneic cord blood (CB), One Unmanipulated and One Expanded Cord Blood Unit, and 7 other interventions for Leukemia, Lymphocytic, Acute and 3 related conditions. Completed, enrolled 110 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphocytic, Acute, Leukemia, Myelocytic, Acute, Leukemia, Myeloid, Chronic, Lymphoma, Non-Hodgkin
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Cellgenix

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2003
Enrollment StartApr 1, 2003
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 13.3 yearsPosted 22.9 years ago

Interventions

Expanded allogeneic cord blood (CB)procedure

Transplantation of Two Unmanipulated Cord Blood Units.

One Unmanipulated and One Expanded Cord Blood Unitprocedure

Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.

Rituxandrug

375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.

Melphalandrug

140 mg/m2 by vein on Day -8.

Thiotepadrug

5 mg/Kg by vein on Day -7.

Fludarabinedrug

40 mg/m2 by vein on Days -6 to -3.

Cyclophosphamidedrug

50 mg/kg by vein on Day -6.

Mesnadrug

10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).

Total body irradiation (TBI)radiation

Total body irradiation (TBI) given on Day -1 at 2 Gy.