Health Trials

About this trial

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Eligibility criteria

Qualifiers

AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).

Secondary AML in 1st remission

AML in 1st relapse or 2nd remission

ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission

Disqualifiers

Female patients who are pregnant or breast-feeding

Active viral, bacterial or fungal infection

Patient seropositive for HIV-I /II; HTLV -I /II

Presence of leukemia in the CNS

Trial design

Treatments tested in this trial

  • Total Body Irradiation (TBI)
  • Thiotepa
  • Cyclophosphamide
  • Busulfan
  • Melphalan
  • Fludarabine

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1
Baptist Health South Florida/Miami Cancer Institute33176, MiamiFlorida, United States

Sponsors and collaborators

Guenther Koehne

Lead sponsor

Baptist Health South Florida

Sponsor institution

Source ClinicalTrials.gov