Back to search results

Campath/Fludarabine/Melphalan Transplant for Non-Malignant Disorders

This study is testing a new way to prepare patients for a stem cell transplant for non-cancerous conditions like metabolic, blood, immune, or bone marrow disorders. It uses a combination of medications including Campath-1H, Fludarabine, and Melphalan to help the body accept donor cells without needing high-dose chemotherapy or radiation. The goal is to reduce side effects like graft-versus-host disease (GVHD), where the donor cells attack the patient's body. The study is looking at how well the donor cells engraft (take hold) and any major side effects within 100 days after the transplant. Children up to 20 years old with these conditions may be able to join, depending on their specific disorder and donor match.

Study design
This is an interventional study planning to enroll 220 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for donor engraftment and major toxicities for 100 days after transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00920972

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

Recruiting
PHASE1Up to 20InterventionalTreatment
Washington University School of Medicine
~220 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:Treatment Plan 1: Stratum 1Treatment Plan 2: Strata 2, 3, or 4GVHD Regimen A: UCB RecipientsGVHD Regimen B: BM Recipients

At a glance

Recruiting sites
12 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Donor engraftment as measured by chimerism
Measured over 100 days post-transplant
+1 more outcome measured

Conditions

Metabolic Disorders
Hematologic, Immune, or Bone Marrow Disorders
Hemoglobinopathies
Non-malignant Disorders

Explore related trials

Bone Marrow DisorderHematopoietic and Lymphoid Cell DisorderHemoglobinopathyImmune System DisorderMetabolic Disorder

Where it's being run

28 sites across 19 states
Florida4
Missouri3
North Carolina3
California2
Texas2
Arizona1
Connecticut1
District of Columbia1

Study leadership

  • Shalini Shenoy, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine (in St. Louis)

Who to contact

Lissy Keller, CCRP
[email protected]
3142861168
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

HIV positive
Invasive infection
Pregnancy/lactating

What this trial measures

  • Donor engraftment as measured by chimerism100 days post-transplant

    Engraftment is measured in myeloid and lymphoid lineage cells

  • Major toxicities as graded by the CTC v4100 days post-transplant

    Toxicity monitoring includes unanticipated side effects (new) and all severe irreversible toxicities Grade 3 and above unexpected Grade 4 and above - all toxicities that are possibly, probably or definitely related to protocol therapy All deaths irrespective of attribution