Allo-hNHL (FluBuCy)
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
standard GVHD prophylaxis
rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring rituximab, Non-Hodgkin's lymphoma, diffuse large B cell lymphoma, peripheral t cell lymphoma, graft-versus-host disease, graft-versus-lymphoma effect, allogeneic haematopoietic stem cell transplantation, relapsed or primary progressive aggressive Non-Hodgkin's lymphoma
Eligibility Criteria
Inclusion Criteria:
- histology proven aggressive non Hodgkin's lymphoma and
- primary progressive disease or
- early relapse after less than 12 month of remission duration and at least one risk factor according to the international prognostic index (IPI or
- relapse or progression after high dose chemotherapy and autologous transplantation or
- relapse or progression and lack of an autologous stem cell product.
Exclusion Criteria:
- severe comorbidity or impaired organ function
- hypersensitivity to used drugs
- HIV positivity
- active hepatitis
- other active malignant disease
Sites / Locations
- Universitätsklinikum Heidelberg
- Universitätsklinikum Marburg
- Universitätsklinikum und Poliklinik
- University Hospital Goettingen
- Asklepios Klinik St. Georg
- KMT-Zentrum Medizinische Klinik A
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
A
B
Arm Description
Patients receiving no rituximab as GVHD prophylaxis after allogeneic SZT and only standard GVHD prophylaxis (tacrolimus with aimed serum level of 10 ng / ml and mycophenolat mofetil 2 x 1 g p.o. day 1 to 28 after allogeneic SZT
rituximab in addition to standard GVHD prophylaxis
Outcomes
Primary Outcome Measures
The specific measure that will be used to determine the effect of the intervention(s) or, for observational studies, related to core objectives of the study and receiving the most emphasis in assessment. (a) rate of acute GVHD grade II-IV after one year
Secondary Outcome Measures
progression free survival, progression rate, non-relapse mortality, rate of grade 3-4 infectious adverse event, chronic GVHD
Full Information
NCT ID
NCT00785330
First Posted
September 13, 2005
Last Updated
January 9, 2020
Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
University Hospital Goettingen, German High-Grade Non-Hodgkin's Lymphoma Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00785330
Brief Title
Allo-hNHL (FluBuCy)
Official Title
Open, Multicentral, Randomised Phase II Study of Allogene Stem Cell Transplantation After Pretreatment With Fludarabin, Busulfan, Cyclophospahmid and GVHD-prophylaxis With or Without Rituximab in Patients With Recidivation of High Grade Non-hodgkin's Lymphoma in Special Risk Situation in the Age of 18 - 65
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
University Hospital Goettingen, German High-Grade Non-Hodgkin's Lymphoma Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the efficacy of rituximab as a prophylactic medication for prevention of graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in this clinical situation.
Detailed Description
Patients in the age of 18 to 65 years with a high- risk relapse of a histology proven aggressive Non-Hodgkin's-lymphoma are eligible for the trial. Aggressive Non-Hodgkin's lymphoma within this study is defined as:
B-NHL:
follicular lymphoma grade III° lymphoblastic (precursor) lymphoma diffuse large cell cell lymphoma any subtype and variant including primary mediastinal lymphoma mantle cell lymphoma, blastic variant
T-NHL:
precursor T cell lymphoma peripheral T cell lymphoma, any subtype and variant angioimmunoblastic lymphoma anaplastic large cell lymphoma, any subtype NK / T cell lymphoma High risk relapsed or progressive disease is defined as (a) primary progressive disease, (b) early relapse after less than 12 month of remission duration and at least one risk factor according to the international prognostic index (IPI), (c) relapse or progression after high dose chemotherapy and autologous transplantation, (d) relapse or progression and lack of an autologous stem cell product.
Patients with this type of progression / relapse should receive rituximab plus ifosfamide/carboplatin/etoposide (R-ICE) or rituximab plus dexamethasone/high dose ARA-C/cisplatinum as salvage therapy (recommendation, not part of study medication). In patients biwth T cell lymphoma rituximab may be replaced by alemtuzumab. If at least stable disease is achieved, patients can be definitely included.
With inclusion, patients were randomized to receive either 375 mg/ m2 of rituximab at weeks 3, 4, 5, 6, 25, 26, 27, 28 after allogeneic stem cell transplantation or no additional medication.
Conditioning for transplantation consisted of Fludarabine 125 mg/m2, Busulfan 12 mg/kg and cyclophosphamide 120 mg/kg.
Short-term (day 1 to day 28) mycophenolat mofetil and tacrolimus are used as basis GVHD prophylaxis in all patients. Anti-thymocyte globulin can be used due to the centres decision in patients with unrelated donors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
rituximab, Non-Hodgkin's lymphoma, diffuse large B cell lymphoma, peripheral t cell lymphoma, graft-versus-host disease, graft-versus-lymphoma effect, allogeneic haematopoietic stem cell transplantation, relapsed or primary progressive aggressive Non-Hodgkin's lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
Patients receiving no rituximab as GVHD prophylaxis after allogeneic SZT and only standard GVHD prophylaxis (tacrolimus with aimed serum level of 10 ng / ml and mycophenolat mofetil 2 x 1 g p.o. day 1 to 28 after allogeneic SZT
Arm Title
B
Arm Type
Experimental
Arm Description
rituximab in addition to standard GVHD prophylaxis
Intervention Type
Drug
Intervention Name(s)
standard GVHD prophylaxis
Intervention Description
Application of tacrolimus from day -1 with a goal of tacrolimus serum concentration of 10 ng / ml Aplication of mycophenolat mofetil from day +1 to day +28 in a dose of 2 x 1g per day
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
Patients receiving 375 mg/ m2 of rituximab at weeks 3, 4, 5, 6, 25, 26, 27, 28 after allogeneic stem cell transplantation in addition to standard GVHD prophylaxis (tacrolimus with aimed serum level of 10 ng / ml and mycophenolat mofetil 2 x 1 g p.o. day 1 to 28 after allogeneic SZT
Primary Outcome Measure Information:
Title
The specific measure that will be used to determine the effect of the intervention(s) or, for observational studies, related to core objectives of the study and receiving the most emphasis in assessment. (a) rate of acute GVHD grade II-IV after one year
Time Frame
One year after allogeneic stem cell transplantation
Secondary Outcome Measure Information:
Title
progression free survival, progression rate, non-relapse mortality, rate of grade 3-4 infectious adverse event, chronic GVHD
Time Frame
one and three years after allogeneic SZT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histology proven aggressive non Hodgkin's lymphoma and
primary progressive disease or
early relapse after less than 12 month of remission duration and at least one risk factor according to the international prognostic index (IPI or
relapse or progression after high dose chemotherapy and autologous transplantation or
relapse or progression and lack of an autologous stem cell product.
Exclusion Criteria:
severe comorbidity or impaired organ function
hypersensitivity to used drugs
HIV positivity
active hepatitis
other active malignant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertram Glass, Prof. MD.
Organizational Affiliation
Asklepios Klinik St. Georg
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Würtenberg
Country
Germany
Facility Name
Universitätsklinikum Marburg
City
Marburg
State/Province
Hessen
Country
Germany
Facility Name
Universitätsklinikum und Poliklinik
City
Homburg
State/Province
Saarland
Country
Germany
Facility Name
University Hospital Goettingen
City
Göttingen
ZIP/Postal Code
D.37075
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
KMT-Zentrum Medizinische Klinik A
City
Münster
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24827808
Citation
Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Gorlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. doi: 10.1016/S1470-2045(14)70161-5. Epub 2014 May 11.
Results Reference
derived
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Allo-hNHL (FluBuCy)
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