NCT01079013UnknownPhase 2
Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Sheba Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- disease-free survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 68 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Overt progressive disease prior to transplantation.
- •Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- •Creatinine > 2.0 mg/dl
- •ECOG-Performance status > 2
- •Uncontrolled infection
- •Pregnancy or lactation
- •Abnormal lung diffusion capacity (DLCO < 40% predicted)
- •Severe cardiovascular disease
- •CNS disease involvement
- •Pleural effusion or ascites > 1 liter
- •Known hypersensitivity to fludarabine or treosulfan
- •Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Arms & Interventions
treosulfan
Experimental
Intervention: treosulfan (Drug)
Outcomes
Primary Outcomes
disease-free survival
Time Frame: 2 years after transplantation
Secondary Outcomes
- relapse(2 year after transplantation)
- overall survival(2 year after transplantation)
- treatment-related mortality(2 year after transplantation)
- GVHD(2 year after transplantation)
Investigators
Study Sites (1)
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