Back to resultsThiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Primary Purpose
Non Hodgkin Lymphoma, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Thiotepa
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 MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
- MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
- Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
- Follicular lymphoma; failure of at least one prior regimen
- CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
- 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, -DQB) 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:
- 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 CenterRecruiting
- Chaim Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
thiotepa
Arm Description
Thiotepa 5-10 mg/kg/d x 2 days
Outcomes
Primary Outcome Measures
disease-free survival
The percentage of patients alive without disease recurrence 2 years after transplant
Secondary Outcome Measures
treatment-related mortality
The percentage of patients who die of complications related to the transplant
graft versus host disease
The percentage of patients experiencing graft-versus-host disease after transplant
relapse
The percentage of patients experiencing disease recurrence after transplant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02507479
Brief Title
Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Official Title
Phase II Trial of Fludarabine Combined With Intravenous Thiotepa and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies Including Multiple Myeloma, Non Hodgkin's, Hodgkin Lymphoma and CLL
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2019 (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 thiotepa, 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, Chronic Lymphocytic Leukemia, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thiotepa
Arm Type
Experimental
Arm Description
Thiotepa 5-10 mg/kg/d x 2 days
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Intervention Description
Chemotherapy given prior to allogeneic stem cell transplantation
Primary Outcome Measure Information:
Title
disease-free survival
Description
The percentage of patients alive without disease recurrence 2 years after transplant
Time Frame
2 years after transplantation
Secondary Outcome Measure Information:
Title
treatment-related mortality
Description
The percentage of patients who die of complications related to the transplant
Time Frame
2 years after transplantation
Title
graft versus host disease
Description
The percentage of patients experiencing graft-versus-host disease after transplant
Time Frame
1 year after transplantation
Title
relapse
Description
The percentage of patients experiencing disease recurrence after transplant
Time Frame
2 years after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age less than physiologic 68 years.
Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
Follicular lymphoma; failure of at least one prior regimen
CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
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, -DQB) 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avichai Shimoni, MD
Phone
972 3 530 5830
Email
ashimoni@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Nagler, MD
Phone
9972 3 530 5830
Email
a.nagler@sheba.health.gov.il
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD
Phone
972 3 530 5830
Email
a.nagler@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Avichai Shimoni, MD
Phone
972 3 530 5303
Email
ashimoni@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Avichai Shimoni, MD
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD
12. IPD Sharing Statement
Learn more about this trial
Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
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