NCT00920972 Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
| NCT ID | NCT00920972 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Washington University School of Medicine |
| Condition | Metabolic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2001-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2001-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Stratum 1: Patient must have non-malignant disorder, excluding thalassemia. Must be receiving a 8/8 HLA-matched bone marrow, related or unrelated Stratum 2: Patient must have thalassemia receiving 8/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated. Stratum 3: Patient must have a hemoglobinopathy receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated. Stratum 4: Patient must have a non-malignant disorder (excluding hemoglobinopathy) receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated. All strata: * Recipient age \< 21 years * Lansky/Karnofsky \>/= 40 * Adequate pulmonary, renal, liver, and other organ function as defined in protocol * Negative pregnancy test * Adequate total nucleated cell or CD34+ dose of product as defined in protocol * If sickle cell, Hemoglobin S \<30% Exclusion Criteria: * HIV positive * Invasive infection * Pregnancy/lactating
Contact & Investigator
Shalini Shenoy, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine (in St. Louis)
Frequently Asked Questions
Who can join the NCT00920972 clinical trial?
This trial is open to participants of all sexes, up to 20 Years, studying Metabolic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT00920972 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT00920972 currently recruiting?
Yes, NCT00920972 is actively recruiting participants. Contact the research team at kellerl@wustl.edu for enrollment information.
Where is the NCT00920972 trial being conducted?
This trial is being conducted at Phoenix, United States, Orange, United States, San Diego, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT00920972 clinical trial?
NCT00920972 is sponsored by Washington University School of Medicine. The principal investigator is Shalini Shenoy, MD at Washington University School of Medicine (in St. Louis). The trial plans to enroll 220 participants.