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

  • STATUS
    Recruiting
  • End date
    Dec 27, 2031
  • participants needed
    220
  • sponsor
    Washington University School of Medicine
Updated on 27 May 2020
Investigator
Lisa Murray, MA, CCRP
Primary Contact
George Washington University School of Medicine (5.4 mi away) Contact
+19 other location
graft versus host disease
fludarabine
melphalan
hemoglobin s
transplant conditioning
preparative regimen
graft-versus-host disease
campath
thalassemia

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.

Description

The study uses reduced intensity conditioning that is immune suppressive to achieve donor cell engraftment without exposure to radiation or high dose chemotherapy in children with non-malignant disorders. The intent is to minimize early and late regimen related toxicities in the context of a reduced intensity regimen.

In addition to maximizing opportunity for donor cell engraftment, the trial seeks to minimize toxicities associated with transplant such as graft versus host disease and employs GVHD prophylaxis that seeks to decrease rates of acute and chronic GVHD in the setting of matched and mismatched donor stem cell transplants from marrow and cord blood sources.

Details
Treatment Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan, Transplant conditioning regimen of hydroxyurea, campath, fludarabine, thiotepa, & melphalan, Treatment Plan 1: Stratum 1, Treatment Plan 2: Strata 2, 3, or 4, GVHD Regimen A: UCB Recipients, GVHD Regimen B: BM Recipients
Clinical Study IdentifierNCT00920972
SponsorWashington University School of Medicine
Last Modified on27 May 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 20 yrs?
Gender: Male or Female
Do you have any of these conditions: Hematologic, Immune, or Bone Marrow Disorders or Hematological Disorders or Non-malignant Disorders or Blood disorder or Metabolic Disorders or Hemogl...?
Stratum 1: Patient must have non-malignant disorder, excluding thalassemia
Must be receiving a 8/8 HLA-matched bone marrow, related or unrelated Stratum
Patient must have thalassemia receiving 8/8 HLA-matched bone marrow or
-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
Clear my responses

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