Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 20, 2016
April 1, 2016
8.1 years
March 1, 2010
April 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
disease-free survival
2 years after transplantation
Secondary Outcomes (4)
treatment-related mortality
2 year after transplantation
GVHD
2 year after transplantation
relapse
2 year after transplantation
overall survival
2 year after transplantation
Study Arms (1)
treosulfan
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaim Sheba Medical Center
Tel Litwinsky, Tel-Hashomer, 52621, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnon Nagler, MD
Chaim Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 2, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 20, 2016
Record last verified: 2016-04