CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Melphalan +4 moredrug
Likely dose
Melphalan 140 mg/m² (day -8), thiotepa 10 mg/kg (day -7), fludarabine 160 mg/m² over 4 days (days -6 to -3), rabbit ATG 1.5 mg/kg daily for 4 days (days -6 to -3), followed by megadose CD34+ selected progenitor cell transplant on day 0AI-extracted
Key inclusion· 10
  • ✓Histopathologically confirmed acute leukemia in second or greater remission, in relapse, or primary refractory disease; or AML with high-risk cytogenetics (-5, -7, t(6:9), +8, -11q23) in first remission; or ALL with Phil+ t(9:22), t(4:11) in any remission
  • ✓CML in accelerated phase, blast crisis, or second chronic phase
  • ✓Myelodysplastic syndrome in high or intermediate risk categories with marrow blast >10%
  • ✓Non-Hodgkin's lymphoma in relapse
Key exclusion· 7
  • ✕Active hepatitis B or C, or cirrhosis
  • ✕HIV positive status (recipient or donor)
  • ✕Active, uncontrolled bacterial, viral, or fungal infection
  • ✕Uncontrolled CNS involvement with tumor cells

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

Search/NCT00038857
NCT00038857Phase 2Completed
CompareCT.gov

Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases

M.D. Anderson Cancer Center·interventional·Posted Jun 7, 2002·Updated Aug 10, 2012

In Brief

A Phase 2 clinical trial evaluating Megadose of CD34 Selected Progenitor Cells, Melphalan, and 3 other interventions for Leukemia and Lymphoma. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease \[GvHD\] (grade III-IV). Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2002
Enrollment StartSep 1, 2001
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 24.1 years ago

Interventions

Megadose of CD34 Selected Progenitor Cellsprocedure

Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0.

Melphalandrug

140 mg/m\^2 on day -8

Thiotepadrug

10 mg/kg on day -7

Fludarabinedrug

160 mg/m\^2 over 4 days on days -6, -5, -4, -3

Rabbit ATGdrug

1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.