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Trial record 1 of 1 for:    NCT01156922
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B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome

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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
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

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
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Norway
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, Norway, N-5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Olav Mella, PhD, MD Haukeland University Hospital

Publications:
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01156922     History of Changes
Other Study ID Numbers: 2010/1321
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

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