Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies

Launched by SHEBA MEDICAL CENTER · Mar 1, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age less than physiologic 68 years.
• 2. Patients with NHL and HL with an indication for allogeneic transplantation as follows:
• • Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
• • Follicular lymphoma; failure of at least one prior regimen
• • 3. Disease must be at chemo-sensitive or stable status to prior therapy before transplant.
• • 4. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient
• • 5. Patients must sign written informed consent
• • 6. Adequate birth control in fertile patients
• Exclusion Criteria:
• • 1. Overt progressive disease prior to transplantation.
• • 2. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
• • 3. Creatinine \> 2.0 mg/dl
• • 4. ECOG-Performance status \> 2
• • 5. Uncontrolled infection
• • 6. Pregnancy or lactation
• • 7. Abnormal lung diffusion capacity (DLCO \< 40% predicted)
• • 8. Severe cardiovascular disease
• • 9. CNS disease involvement
• • 10. Pleural effusion or ascites \> 1 liter
• • 11. Known hypersensitivity to fludarabine or treosulfan
• • 12. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate