WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS
Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS] .
Infusion Reactions : Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS] .
Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] .
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NEWS HIGHLIGHTSMedia Articles Related to Campath (Alemtuzumab)
Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
Source: Health News from Medical News Today [2009.11.19]
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S.
Finding May Give Hope To More Leukemia Patients So They May Live Cancer-Free
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.16]
A new study from the Masonic Cancer Center, University of Minnesota shows that patients who have acute leukemia and are transplanted with two units of umbilical cord blood (UCB) have significantly reduced risk of the disease returning. This finding has the potential to change the current medical practice of using one unit of UCB for treatment of patients who are at high risk for recurrence of leukemia and other cancers of the blood and bone marrow. Michael Verneris, M.D.
Leukemia Drug May Help Some Ovarian Cancer Patients (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.12]
HealthDay - THURSDAY, Nov. 12 (HealthDay News) -- A drug for people with a form of
leukemia holds promise as a possible treatment for ovarian cancer, new
research suggests.
Leukemia Drug May Help Some Ovarian Cancer Patients
Source: MedicineNet Leukemia Specialty [2009.11.12]
Title: Leukemia Drug May Help Some Ovarian Cancer Patients
Category: Health News
Created: 11/12/2009 8:10:00 AM
Last Editorial Review: 11/12/2009
FDA Approved Leukemia Drug Shows Promising Activity In Ovarian Cancer Cells
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.11]
The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA's Jonsson Comprehensive Cancer Center found.
Published Studies Related to Campath (Alemtuzumab)
Results of a phase I/II British Society of Bone Marrow Transplantation study on PCR-based pre-emptive therapy with valganciclovir or ganciclovir for active CMV infection following alemtuzumab-based reduced intensity allogeneic stem cell transplantation. [2009.02]
This multi-centre randomized study assessed the bioavailability of ganciclovir in patients undergoing alemtuzumab-based reduced intensity conditioning (RIC) haematopoietic stem cell transplantation (HSCT) after oral administration of valganciclovir. Patients were randomized to 2 groups receiving either oral valganciclovir (900 mg twice daily) or intravenous ganciclovir (5mg/kg twice daily) for 14 days...
Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG). [2009.01]
Alemtuzumab has shown considerable activity in untreated and relapsed chronic lymphocytic leukaemia. We report our long-term experience in 21 patients within a randomized phase III trial investigating the role of alemtuzumab for consolidation therapy after first-line fludarabine +/- cyclophosphamide, which was stopped prematurely due to severe infections...
Campath-1H (alemtuzumab) as an induction agent for the prevention of graft rejection and preservation of renal function in kidney transplant patients: Philippine 3-year follow-up. [2008.09]
OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of induction with Campath-1H with low-dose cyclosporine (CsA) monotherapy using outcome measures of acute rejection episodes (ARE), chronic allograft nephropathy (CAN), graft and patient survivals, as well as malignancies and infections... CONCLUSIONS: Three years posttransplantation, patients given Campath induction with CsA monotherapy showed a greater incidence of ARE, although renal function remained comparable to CsA-azathioprine-prednisone therapy. AREs were easily reversed with steriods. Infections were minor.
Calcineurin inhibitor withdrawal after renal transplantation with alemtuzumab: clinical outcomes and effect on T-regulatory cells. [2008.07]
To address the results of calcineurin inhibitor (CNI) withdrawal after alemtuzumab induction relative to CNI continuation, we performed a pilot randomized clinical trial in renal allograft recipients on CNI, a mycophenolic acid derivative and steroids after the first 2 months posttransplantation...
Alemtuzumab (Campath-1H) and tacrolimus monotherapy after renal transplantation: results of a prospective randomized trial. [2008.07]
The lymphocyte-depleting antibody alemtuzumab was evaluated in a prospective randomized multicenter trial in deceased donor kidney transplantation. The 65 patients in the study group received induction with alemtuzumab followed by delayed tacrolimus monotherapy, while the 66 patients in the control group were started on tacrolimus in combination with mycophenolate mofetil and steroids...
Clinical Trials Related to Campath (Alemtuzumab)
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia [Recruiting]
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and
safety of subcutaneously administered CAMPATH as therapy for patients with relapsed or
refractory B-CLL who have been previously treated.
Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia [Recruiting]
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface
of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells.
Adult patients with ALL in relapse have less than 10% probability of long term survival. The
present study will test the response rate (partial and complete remission) of refractory ALL
or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be
given for a hematopoietic stem cell transplant.
The use of G-CSF is justified by a possible increase in ADCC.
Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma [Recruiting]
Primary Objectives:
1. To evaluate the role of autologous and allogenic stem cell transplantation with
Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
2. To examine the impact of in-vivo purging with Campath - 1H pre-autologous stem
transplantation for patients with PTCL.
3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
4. To evaluate the role of Campath - 1H in the treatment minimal residual disease after
autologous transplantation for PTCL.
Alemtuzumab + Rituximab Consolidation in CLL [Recruiting]
The goal of this clinical research study is to find out how well Campath (alemtuzumab),
Rituxan (rituximab), or a combination of the 2 drugs may control CLL that is left after
chemotherapy. The safety of these drugs will also be studied.
Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL) [Recruiting]
Patients will be treated with bendamustine at a fixed, standard dose. Escalating doses of
alemtuzumab will be administered. A cycle is defined as a 4 week period with alemtuzumab
administered on Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26.
Patients will be enrolled and treated within 28 days after screening. Alemtuzumab and
bendamustine will be administered to cohorts of at least 3 patients. Dose escalation will
occur by sequential cohort. Escalation of subsequent cohorts will occur no sooner than 28
days after the last patient in the cohort receives the first cycle Day 1 of treatment. Dose
escalation will only occur in the absence of protocol specified dose limiting criteria at
the current dose.
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