Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
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ClinicalTrials.gov Identifier: NCT01079013
Recruitment Status : Unknown
Verified April 2016 by Sheba Medical Center. Recruitment status was: Active, not recruiting
The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.
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Ages Eligible for Study:
18 Years to 68 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age less than physiologic 68 years.
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
Disease must be at chemo-sensitive or stable status to prior therapy before transplant.
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
Patients must sign written informed consent
Adequate birth control in fertile patients
Overt progressive disease prior to transplantation.
Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit