Allo-hNHL (FluBuCy)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University Hospital Goettingen
German High-Grade Non-Hodgkin's Lymphoma Study Group
Information provided by:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT00785330
First received: September 13, 2005
Last updated: April 16, 2009
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: standard GVHD prophylaxis
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

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 [ Time Frame: One year after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2004
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
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
Drug: standard GVHD prophylaxis
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
Experimental: B
rituximab in addition to standard GVHD prophylaxis
Drug: rituximab
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785330

Locations
Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Würtenberg, Germany
Universitätsklinikum Marburg
Marburg, Hessen, Germany
Universitätsklinikum und Poliklinik
Homburg, Saarland, Germany
University Hospital Goettingen
Göttingen, Germany, D.37075
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
KMT-Zentrum Medizinische Klinik A
Münster, Germany
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Hospital Goettingen
German High-Grade Non-Hodgkin's Lymphoma Study Group
Investigators
Study Director: Bertram Glass, Prof. MD. Asklepios Klinik St. Georg
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. Glass, University Hospital Goettingen, Germany
ClinicalTrials.gov Identifier: NCT00785330     History of Changes
Other Study ID Numbers: DSHNHL 2004-R3
Study First Received: September 13, 2005
Last Updated: April 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014