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

ConditionsMetabolic Disorders Hematologic, Immune, or Bone Marrow Disorders Hemoglobinopathies Non-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

Locations

Canada

BC Children's HospitalV6H 3N1, VancouverBritish Columbia, Canada

University of ManitobaMB R3E 0T4, WinnipegManitoba, Canada

University of Calgary Calgary Canada

United States

Arizona

Phoenix Children's Hospital85016, Phoenix United States

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor

St. Louis Children's Hospital

Collaborator

Source ClinicalTrials.gov