Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue

• Status: Withdrawn
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether armodafinil is more effective than placebo in reducing fatigue.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria for both arms:

• Age ≥ 18 with diagnosis of B-cell lymphoma

• Average score of ≥ 7 on daily worst fatigue severity assessment from the BFI questionnaire during screening

• Able to demonstrate appropriate use of the wrist actigraphy device and to complete questionnaires

• ECOG performance status 0-2

• Laboratory values:

• Hemoglobin ≥ 10 g/dL

• Total Bilirubin ≤ 1.5 x institutional ULN

• AST/ALT ≤ 2.5 x institutional ULN

• Creatinine ≤ 1.5 x institutional ULN

• Albumin ≥ 3.5 g/dl

• Life expectancy > 6 months

• IRB-approved informed consent form must be signed before any protocol-specific screening procedures are performed.

Inclusion criteria for patients undergoing R-CHOP chemotherapy:

• Scheduled to receive 6 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as first-line treatment

Inclusion criteria for patients in remission following chemotherapy and/or radiotherapy:

• May have received one prior regimen of chemotherapy and/or radiotherapy

• Adequate response to upfront chemotherapy and/or radiotherapy

• Indolent lymphomas - must have achieved a partial or complete response with no immediate plans for further treatment

• Aggressive lymphomas - must have achieved a complete response:

• ≥ 4 weeks since completion of chemotherapy

• ≥ 8 weeks since completion of radiotherapy

• ≤ 18 months since completion of chemotherapy or radiotherapy

Exclusion Criteria for both arms:

• Uncontrolled medical and/or psychiatric condition that may cause fatigue or that the PI feels is clinically significant and might adversely affect patient safety (such as sleep disorders, moderate/severe depression, metabolic/endocrine abnormalities, infections)

• History of clinically significant cardiac disorders, such as left ventricular hypertrophy or mitral valve prolapse experienced in conjunction with receiving CNS stimulants

• History of serious skin reactions, such as serious rash or Stevens-Johnson Syndrome

• Concurrent stimulant medication

• Any other active malignancy within the past 3 years except cervical carcinoma in situ and non-melanoma skin cancers

• Known CNS involvement by lymphoma

• Cachexia

• Use of opioids at time of randomization

• Known sensitivity to modafinil and/or armodafinil