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Non-Hodgkin's LymphomaPhase 2NCT00785330

Allo-hNHL (FluBuCy)

A Phase 2 study testing standard GVHD prophylaxis and rituximab in people with Non-Hodgkin's Lymphoma, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
standard GVHD prophylaxis and rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
6 sitesGermany
Study dates
Apr 2004to Apr 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • University Hospital Goettingen

    Göttingen, D.37075

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Würtenberg

  • Universitätsklinikum und Poliklinik

    Homburg, Saarland

  • Universitätsklinikum Marburg

    Marburg, Hesse

  • KMT-Zentrum Medizinische Klinik A

    Münster

Other trials in Germany

About this study

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

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.

Read the 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

Being tested
standard GVHD prophylaxis, rituximab
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
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell, Peripheral, Graft vs Host Disease, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard GVHD prophylaxisDrug

    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

  • rituximabDrug

    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

Study groups in NCT00785330
Study groupRoleWhat they receive
AOtherPatients 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
Receives: Drug: standard GVHD prophylaxis
BExperimentalrituximab in addition to standard GVHD prophylaxis
Receives: Drug: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: One year after allogeneic stem cell transplantation

Secondary outcomes (1)

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

    Measured: one and three years after allogeneic SZT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2008 (estimated)
  2. Study startApr 2004
  3. Primary completionMar 2009
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00785330
Sponsor's protocol ID
DSHNHL 2004-R3
Status last verified
Jan 2020
First submitted
13 Sep 2005
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24827808

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing standard GVHD prophylaxis and rituximab in people with Non-Hodgkin's Lymphoma, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00785330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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