Health Trials

Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

ConditionsMetabolic DisordersHematologic, Immune, or Bone Marrow DisordersHemoglobinopathiesNon-malignant Disorders
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 20
SponsorWashington University School of Medicine

About this trial

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

Eligibility criteria

Qualifiers

Recipient age < 21 years

Lansky/Karnofsky >/= 40

Adequate pulmonary, renal, liver, and other organ function as defined in protocol

Negative pregnancy test

Disqualifiers

HIV positive

Invasive infection

Pregnancy/lactating

Trial design

Treatments tested in this trial

  • Treatment Plan 1: Stratum 1
  • Treatment Plan 2: Strata 2, 3, or 4
  • GVHD Regimen A: UCB Recipients
  • GVHD Regimen B: BM Recipients

Treatment groups

220 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor

St. Louis Children's Hospital

Collaborator

Source ClinicalTrials.gov