B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome
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Purpose
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.
The hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
An approved amendment (April 15th 2011): the study will be extended with up to 5 patients. For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of B-lymphocyte depletion using Rituximab (as in the protocol).
Approved amendment (December 2011): for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Fatigue Syndrome Myalgic Encephalomyelitis |
Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Severely Affected Chronic Fatigue Syndrome Patients. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment for Patients in WHO Performance Status III-IV |
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes [ Time Frame: Major response of at least six weeks duration, independent on when occuring, during the follow-up period ] [ Designated as safety issue: Yes ]The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention ] [ Designated as safety issue: Yes ]The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)
| Enrollment: | 8 |
| Study Start Date: | June 2010 |
| Study Completion Date: | April 2016 |
| Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rituximab
Rituximab induction two infusions (500 mg/m2, max 1000 mg) two weeks apart, followed by maintenance Rituximab infusions (500 mg/m2, max 1000 mg) after 3, 6, 10 and 15 months.
|
Drug: Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months. For up to 5 patients in the study, standard plasma exchange (one plasma volume, up to 5 treatments, during 1-2 weeks) will be performed 2-3 weeks prior to start of Rituximab therapy. Amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period. |
Eligibility| Ages Eligible for Study: | 18 Years to 66 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients severely affected by chronic fatigue syndrome, in WHO performance status III or IV.
- age 18-66 years
- informed consent
Exclusion Criteria:
- patients with fatigue, not fulfilling criteria for CFS
- pregnancy or lactation
- previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
- previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
- endogenous depression
- lack of ability to comply by the protocol
- multi-allergy with risk of serious drug reaction
- reduced renal function (creatinin > 1.5 x upper normal limit [UNL])
- reduced liver function (bilirubin or transaminases > 1.5 x UNL)
- HIV positivity
- evidence of clinically significant infection
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01156922
| Norway | |
| Department of Oncology and Medical Physics, Haukeland University Hospital | |
| Bergen, Norway, N-5021 | |
| Principal Investigator: | Olav Mella, PhD, MD | Haukeland University Hospital |
More Information
Publications:
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT01156922 History of Changes |
| Other Study ID Numbers: | 2010/1321 |
| Study First Received: | July 2, 2010 |
| Last Updated: | April 11, 2016 |
| Health Authority: | Norway: Regional Ethics Commitee Norway: Norwegian Medicines Agency Norway: Directorate of Health |
Keywords provided by Haukeland University Hospital:
|
Chronic fatigue syndrome CFS Myalgic encephalomyelitis Rituximab B-cell depletion |
Additional relevant MeSH terms:
|
Syndrome Fatigue Fatigue Syndrome, Chronic Encephalomyelitis Myalgia Disease Pathologic Processes Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Central Nervous System Diseases |
Nervous System Diseases Neuromuscular Diseases Central Nervous System Infections Musculoskeletal Pain Pain Neurologic Manifestations Rituximab Antibodies Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 26, 2016