The company said the Adcetris approvals were bases on data from two open-label, single-arm clinical trials: a pivotal trial in Hodgkin lymphoma patients who relapsed after ASCT
and a pivotal trial in relapsed systemic ALCL patients.
Approximately 8 months after ASCT
, the patient developed multifocal bone pain and was found to have an increased serum IgD concentration of 0.
In this report, we describe a case of primary AL amyloidosis in a young patient with isolated kidney involvement and rapid progression to ESRD, treated successfully with melphalan and ASCT
A French group randomized 100 patients aged 18 to 70 between the foregoing melphalan-dexamethasone regimen and high-dose melphalan with ASCT
After a median follow-up of 3 years, median OS was 56.
The goal of this phase II trial was to evaluate the safety and efficacy of combining RIT with high-dose carmustine, cytarabine, etoposide, and melphalan (BEAM) chemotherapy and ASCT
in patients with relapsed or refractory NHL.
ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT
and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients.
Thal/Dex was associated with an increased response rate before, but not after, therapy with high-dose melphalan and ASCT
6 shows the BCR-ABL mRNA expression normalized to GAPDH mRNA expression for two different CML patients who received [alpha]-interferon ([alpha]-IFN) + hydroxyurea (HU) followed by ASCT
Specifically, Ashton said the ASCT
recommends mandatory proficiency testing of cytotechnologists and pathologists; workload guidelines based on ASCT
recommendations; documentation of those workloads; retrospective screening of negative Pap smears from high-risk patients; and lab inspection by trained, experienced cytotechnologists.
ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): (1) following autologous stem cell transplant (ASCT
), or (2) following at least two prior therapies when ASCT
or multi-agent chemotherapy is not a treatment option.
Cyclophosphamide and dexamethasone (CD) was commenced 6 months post-transplantation; however, disease progression continued and 2 years post ASCT
bortezomib monotherapy was started at the dose of 1.
Food and Drug Administration (FDA) in August 2011 for two indications: (1) the treatment of patients with HL after failure of ASCT
or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT
candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.