Stem Cell Transplantation for Patients With Graft Failure Following an Allogeneic Transplant, Using Identical or Near Identical Donors and Less Toxic Conditioning With CAMPATH 1H

• Status: Terminated
• Trial end date: 2003-10-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety, feasibility, and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H used as a preparative regimen for HLA-identical sibling blood stem cell transplantation (SCT).

To assess the safety, feasibility, and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a preparative regimen for matched unrelated or single antigen mismatched family donor marrow transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: Texas Children's Hospital; The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Alemtuzumab; Fludarabine

Criteria

INCLUSION CRITERIA

• Diagnosis of engraftment failure either primary or secondary, following allogeneic transplantation. Graft failure is defined as absolute neutrophil count < 500/mm3 and/or platelet count < 20,000/mm3. Primary graft failure is defined as failure to maintain absolute neutrophil count > / = 500/mm3 for 3 consecutive days following allogeneic transplantation. Secondary graft failure is defined as failure to sustain an absolute neutrophil count > / = 500/mm3 after attainment of primary engraftment or failure to sustain platelet count > / = 20,000/mm3 despite neutrophil engraftment. For SCID patients, graft failure is defined as failure to recover > / = 500/mm3 T-cells and/or failure to generate satisfactory response to in vitro mitogen stimulation. For patients with genetic diseases, engraftment failure is defined as donor chimerism insufficient to correct or overcome the genetic or metabolic deficiency.

• Available Healthy Donor without any contraindications for donation (5/6 or 6/6 related donor or 5/6 or 6/6 unrelated donor (molecular typing for DRB1)

• Age between birth and 65

• For women of childbearing potential, negative pregnancy test

EXCLUSION CRITERIA

• Pregnant and lactating women or women unwilling to use contraception.

• Uncontrolled intercurrent infection

• Refractory AML or ALL

• Untreated Blast Crisis for CML

• Uncontrolled High-grade lymphoproliferative disease/lymphoma

• Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

• Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)

• Hemodialysis dependent

• Active Hepatitis or cirrhosis with total bilirubin, SGOT, or SGPT greater than 3 x normal.

• Concurrent solid organ malignancy not in remission, except for Stage 0 or A prostate cancer.

• Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)

• Active CNS disease from hematological disorder.