Lymphoma Clinical Trial

Combination Chemotherapy w w/o Auto Transplant for Central Nervous System B-Cell Lymphoma (CALGB 51101)
A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma

Clinical Trials.gov # NCT01511562

Summary:
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient’s blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.
Eligibility Criteria (must meet the following to participate in this study)
DISEASE CHARACTERISTICS:
•         Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following:
o    Brain biopsy or resection<<
o    Cerebrospinal fluid<<
o    Vitreous fluid<<
•         No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS<
•         No isolated ocular lymphoma or isolated leptomeningeal lymphoma<
•         At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length)<
PATIENT CHARACTERISTICS:
•         Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years)<
•         Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥ 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted)<
•         Pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)<
•         Negative human immunodeficiency virus (HIV) serology<
•         Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative)<
•         Absolute neutrophil count (ANC) ≥ 1500/mcL<
•         Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (ULN)<
•         Total bilirubin ≤ 3 mg/dL<
•         Creatinine clearance ≥ 50 mL/min<
•         Platelet count ≥ 100,000/mcL<
PRIOR CONCURRENT THERAPY:
•         No prior chemotherapy or radiation therapy for lymphoma<
•         No history of organ transplantation or ongoing immunosuppressant therapy<
•         No concurrent palliative radiotherapy<
Contact:
Investigator: Maciej M. Mrugala, MD
Research Coordinator: Alisa Claeys. Phone 206-616-4925
University of Washington Medical Center, Seattle, WA 98195
Seattle Cancer Care Alliance, Seattle, WA 98109

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Pradaxa (dabigatran): Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

AUDIENCE: Cardiology, Patient, Pulmonology, Internal Medicine, Orthopedics, Neurology
ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.

BACKGROUND: Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF).

RECOMMENDATION: Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Press Release and Class I Recall notice, here. (Posted 05/14/14)

 

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