Graft Versus Host DiseasePhase 2R-GVHDNCT01135641
Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD)
A Phase 2 study testing Rituximab, Ciclosporine and Corticosteroids in people with Graft Versus Host Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Rituximab, Ciclosporine and Corticosteroids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) who have received a first allogeneic stem cell transplantation for a hematological disease
- Confirmed diagnosis of first episode of chronic GVHD requiring systemic immunosuppressive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Consensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the different clinical manifestations including :
- Ocular, oral and mucosal symptoms,
- Performance status evaluation,
- Pulmonary function evaluation,
- Cutaneous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible,
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- Evaluation of the musculoskeletal manifestations, especially the amplitude of the rele-vant articulations,
- Evaluation of liver involvement (Total bilirubin, Transaminases, Phosphatase alcalines and Gamma GT).
- Any source of hematopoietic stem cells is authorized.
- Any category of conditioning regimen prior to allo-SCT is authorized.
- Any type of stem cell donors is authorized.
- Signed informed consent.
- Any prior GVHD prophylaxis previously used is accepted.
- Absence of contra-indications to the use of Rituximab.
- Subjects affiliated with an appropriate social security system.
- Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 3 months following the end of the study.
Who cannot join
- Patient developing acute GVHD (whether early or "late onset" form)
- A "limited" form of chronic GVHD not requiring systemic immunosuppressive therapy
- Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment.
- GVHD occurring following donor lymphocytes infusion (DLI)
- Not the first episode of chronic GVHD needing systemic immunosuppressive therapy
- Neutropenia <500/µL
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- Second allogeneic stem cell transplant
- Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 month after the start of therapy
- Severe neurological or psychiatric disorders
- Denied informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab
The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.
- Conditions
- Graft Versus Host Disease
- Being tested
- Rituximab, Ciclosporine, Corticosteroids
- Keywords
- Adult patients (≥18 years), first allogeneic stem cell transplantation, first episode of chronic GVHD requiring systemic immunosuppressive therapy
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Patients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks.
CiclosporineDrug
CorticosteroidsDrug
| Study group | Role | What they receive |
|---|---|---|
| Rituximab, ciclosporine and corticosteroids | Experimental | As soon as the diagnosis of chronic GVHD requiring systemic immunosuppressive therapy is confirmed, patients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks.Rituximab should be administered within 14 days of starting prednisone. Follow-up dates for response assessment and laboratory tests relate to the date of Rituximab infusion.Patients having a partial response after the 1st cycle of Rituximab will be eligible to receive a second cycle of 4 infusions during 4 weeks. A delay of 8 weeks (from the first infusion of Rituximab) will be observed between the two cycles of Rituximab therapy.Patients who relapse after an initial treatment with one cycle of 4 infusions of Rituximab will be eligible to receive a second cycle of Rituximab therapy. Receives: Drug: Rituximab; Drug: Ciclosporine; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate at 12 months
Response rate (complete and partial remission) at 12 months after diagnosis of chronic GVHD and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.
Secondary outcomes (4)
Number of participants with adverse events as a measure of safety and tolerability
To spare patients from long-term use of corticosteroids (and of their long-term side effects)
Treatment failure
To document treatment failure-defined as initiation of another immunosuppressive agent
Transplant-related mortality
To decrease transplant-related mortality (TRM) of infectious and non-infectious origin
Quality of life
To improve quality of life parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad MOHTY, Profesor, Principal investigator, Hôpital Saint-Antoine (Paris)Noël MILPIED, Profesor, Study chair, University Hospital, BordeauxMauricette MICHALLET, Profesor, Study chair, Hospices Civils de LyonKarin BILGER, Doctor, Study chair, CHRU de StrasbourgOumédaly REMAN, Doctor, Study chair, CHRU de CaenIbrahim YAKOUB-AGHA, Profesor, Study chair, CHRU de LilleDidier BLAISE, Profesor, Study chair, Institut Paoli-CalmettesPatrice CEBALLOS, Doctor, Study chair, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135641
- Sponsor's protocol ID
- BRD/09/06-B
- Other IDs
- 2009-016898-14, 2009
- Acronym
- R-GVHD
- Status last verified
- Apr 2014
- First submitted
- 1 Jun 2010
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malard F, Labopin M, Yakoub-Agha I, Chantepie S, Guillaume T, Blaise D, Tabrizi R, Magro L, Vanhove B, Blancho G, Moreau P, Gaugler B, Chevallier P, Mohty M. Rituximab-based first-line treatment of cGVHD after allogeneic SCT: results of a phase 2 study. Blood. 2017 Nov 16;130(20):2186-2195. doi: 10.1182/blood-2017-05-786137. Epub 2017 Sep 1.
PubMed 28864814
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab
- ClinicalTrials.gov ID
- NCT01135641
- Acronym / sponsor ID
- R-GVHD / BRD/09/06-B
- Conditions
- Graft Versus Host Disease
- Keywords
- Adult patients (≥18 years), first allogeneic stem cell transplantation, first episode of chronic GVHD requiring systemic immunosuppressive therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab, ciclosporine and corticosteroids | Experimental | Drug: Rituximab, Drug: Ciclosporine, Drug: CorticosteroidsAs soon as the diagnosis of chronic GVHD requiring systemic immunosuppressive therapy is confirmed, patients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks.Rituximab should be administered within 14 days of starting prednisone. Follow-up dates for response assessment and laboratory tests relate to the date of Rituximab infusion.Patients having a partial response after the 1st cycle of Rituximab will be eligible to receive a second cycle of 4 infusions during 4 weeks. A delay of 8 weeks (from the first infusion of Rituximab) will be observed between the two cycles of Rituximab therapy.Patients who relapse after an initial treatment with one cycle of 4 infusions of Rituximab will be eligible to receive a second cycle of Rituximab therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult patients (≥18 years) who have received a first allogeneic stem cell transplantation for a hematological disease
- Confirmed diagnosis of first episode of chronic GVHD requiring systemic immunosuppressive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Consensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the different clinical manifestations including :
- Any source of hematopoietic stem cells is authorized.
- Any category of conditioning regimen prior to allo-SCT is authorized.
- Any type of stem cell donors is authorized.
Key exclusion criteria (11 listed)
- Patient developing acute GVHD (whether early or "late onset" form)
- A "limited" form of chronic GVHD not requiring systemic immunosuppressive therapy
- Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment.
- GVHD occurring following donor lymphocytes infusion (DLI)
- Not the first episode of chronic GVHD needing systemic immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabPatients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks. | Drug | Rituximab, ciclosporine and corticosteroids |
| Ciclosporine | Drug | Rituximab, ciclosporine and corticosteroids |
| Corticosteroids | Drug | Rituximab, ciclosporine and corticosteroids |
Primary outcome
Response rate at 12 months
Response rate (complete and partial remission) at 12 months after diagnosis of chronic GVHD and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.
4 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability
Treatment failure
Transplant-related mortality
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 28864814Malard F, Labopin M, Yakoub-Agha I, Chantepie S, Guillaume T, Blaise D, Tabrizi R, Magro L, Vanhove B, Blancho G, Moreau P, Gaugler B, Chevallier P, Mohty M. Rituximab-based first-line treatment of cGVHD after allogeneic SCT: results of a phase 2 study. Blood. 2017 Nov 16;130(20):2186-2195. doi: 10.1182/blood-2017-05-786137. Epub 2017 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamad MOHTY, Profesor principal investigator
Hôpital Saint-Antoine (Paris)
Noël MILPIED, Profesor study chair
University Hospital, Bordeaux
Mauricette MICHALLET, Profesor study chair
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Ciclosporine and Corticosteroids in people with Graft Versus Host Disease, run by Nantes University Hospital at 1 site in France.
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 16 inclusion and 11 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Response rate at 12 months. 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 NCT01135641, 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 14 Sep 2026.