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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jun 15, 2009

Keywords

ClinConnect Summary

This clinical trial is studying a new way to prepare patients for a bone marrow transplant using a combination of medications called Campath, Fludarabine, and Melphalan. The goal is to find out if this approach can effectively suppress the immune system to allow donor cells to grow without completely destroying the patient’s bone marrow. The researchers also want to learn about any significant side effects that might occur within the first 100 days after the transplant.

To participate in this trial, patients must be under 21 years old and have a non-cancerous blood disorder, such as certain metabolic or immune conditions. They need to have a matched bone marrow donor or umbilical cord blood that meets specific criteria. Patients who are pregnant, have HIV, or active infections are not eligible. If enrolled, participants can expect close monitoring for side effects and support throughout the process as they receive the transplant. This trial is currently looking for participants, and it could offer hope for those with these challenging health conditions.

Gender

ALL

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