Back to resultsTreosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Primary Purpose
Non Hodgkin Lymphoma, Hodgkin Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
treosulfan
Sponsored by
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma
Eligibility Criteria
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
Sites / Locations
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treosulfan
Arm Description
Outcomes
Primary Outcome Measures
disease-free survival
Secondary Outcome Measures
treatment-related mortality
GVHD
relapse
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01079013
Brief Title
Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Official Title
Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma, Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treosulfan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
treosulfan
Intervention Description
12 g/m2 x 3 days
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
2 years after transplantation
Secondary Outcome Measure Information:
Title
treatment-related mortality
Time Frame
2 year after transplantation
Title
GVHD
Time Frame
2 year after transplantation
Title
relapse
Time Frame
2 year after transplantation
Title
overall survival
Time Frame
2 year after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD
Organizational Affiliation
Chaim Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
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