Allo-hNHL (FluBuCy)

NCT00785330 | Completed Phase 2 DMC

• 1 other identifier: DSHNHL 2004-R3
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  One year after allogeneic stem cell transplantation

Secondary Outcomes (1)

• progression free survival, progression rate, non-relapse mortality, rate of grade 3-4 infectious adverse event, chronic GVHD

  one and three years after allogeneic SZT

Study Arms (2)

A

OTHER

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

B

EXPERIMENTAL

rituximab in addition to standard GVHD prophylaxis

Drug: rituximab

Interventions

standard GVHD prophylaxis DRUG

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

A

rituximab DRUG

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

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• severe comorbidity or impaired organ function
• hypersensitivity to used drugs
• HIV positivity
• active hepatitis
• other active malignant disease

Sponsors & Collaborators

• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: lead
• University Hospital Goettingen: collaborator
• German High-Grade Non-Hodgkin's Lymphoma Study Group: collaborator

Study Sites (6)

Universitätsklinikum Heidelberg

Heidelberg, Baden-Würtenberg, Germany

Location

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Location

Universitätsklinikum und Poliklinik

Homburg, Saarland, Germany

Location

University Hospital Goettingen

Göttingen, D.37075, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

KMT-Zentrum Medizinische Klinik A

Münster, Germany

Location

Related Publications (1)

• 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.

  PMID: 24827808 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell, Peripheral; Graft vs Host Disease; Recurrence

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, T-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bertram Glass, Prof. MD.

  Asklepios Klinik St. Georg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: November 5, 2008
• Study Start: April 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2011
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

DE (6)