B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01156922 |
Recruitment Status :
Terminated
(Difficulties in logistics handling the very severe patients (travel, hospital stay, follow-up))
First Posted : July 5, 2010
Last Update Posted : April 12, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Fatigue Syndrome Myalgic Encephalomyelitis | Drug: Rituximab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
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. |
- 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 ]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 ]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)

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 66 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156922
Norway | |
Department of Oncology and Medical Physics, Haukeland University Hospital | |
Bergen, Norway, N-5021 |
Principal Investigator: | Olav Mella, PhD, MD | Haukeland University Hospital |
Responsible Party: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT01156922 |
Other Study ID Numbers: |
2010/1321 |
First Posted: | July 5, 2010 Key Record Dates |
Last Update Posted: | April 12, 2016 |
Last Verified: | April 2016 |
Chronic fatigue syndrome CFS Myalgic encephalomyelitis Rituximab B-cell depletion |
Fatigue Syndrome, Chronic Encephalomyelitis Myalgia Syndrome Fatigue Disease Pathologic Processes Virus Diseases Infections Muscular Diseases Musculoskeletal Diseases Central Nervous System Diseases |
Nervous System Diseases Neuromuscular Diseases Central Nervous System Infections Musculoskeletal Pain Pain Neurologic Manifestations Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |