0000000000400201
AUTHOR
Lothar Bergmann
showing 7 related works from this author
Induction Therapy with Idarubicin, Ara-C, and VP-16, Followed by G-CSF and Maintenance Immunotherapy with Interleukin-2 for High-Risk AML
1996
Aggressive chemotherapy followed by administration of G-CSF and maintenance therapy with interleukin-2 was evaluated in 16 patients with advanced myelodxysplastic syndrome, 47 patients with AML evolving from myelodysplastic syndromes, 3 patients with subacute myeloid leukemia and 5 patients with secondary AML. Median age was 59 years (range: 23 to 76 years). All patients achieving a complete remission (CR) after two induction courses went on to receive two consolidation courses, to be followed by randomization to either high-dose or low-dose IL-2 to evaluate the potential of IL-2 to eliminate residual leukemic cells and to prolong the duration of CR. Patients ≤ age 55 with an HLA identical …
Chemotherapy with Idarubicin, Ara-C,VP-16, Amsacrine, Followed by G-CSF and Maintenance Immunotherapy with Interleukin-2 for Patients with High-Risk …
1998
To improve the complete remission (CR) rate and to prolong CR duration in patients with advanced MDS, AML evolving from MDS, and secondary AML, a phase-III trial of aggressive chemotherapy followed by G-CSF was initiated in January 1992. Pts. achieving a CR were randomized to receive either high-dose or low-dose IL-2 to evaluate the potential of this cytokine to eliminate residual leukemic cells and to prolong the CR duration.
Progression-free survival as an end-point in clinical trials of biotherapeutic agents
2007
Abstract Progression-free survival (PFS), the time from registration or randomisation of a patient until objective disease progression or death, can be considered as an outcome for clinical research and also as a basis for regulatory approval. Current experience suggests that greater standardisation and consistency are needed for clinical trials utilising PFS endpoints. To this end, the Biotherapy Development Association (BDA) convened a breakout session on the topic of PFS during its Third Alpine Meeting held 14–16 March 2007. Representatives of the pharmaceutical industry, regulatory agencies, academia, and patient advocacy groups identified challenges, developed recommendations, and work…
Prospective randomized trial to evaluate two delayed granulocyte colony stimulating factor administration schedules after high-dose cytarabine therap…
2002
In acute lymphoblastic leukemia (ALL), treatment with granulocyte colony stimulating factor (G-CSF) during remission induction shortens granulocytopenia and may decrease morbidity due to infections. However, the optimal timing of G-CSF administration after chemotherapy is not known. In a prospective randomized multi-center study, adult ALL patients were treated with high-dose ARA-C [HDAC, 3 g/m(2) bid (1 g/m(2) bid for T-ALL) days 1-4] and mitoxantrone (MI 10 mg/m(2) days 3-5). They were randomized to receive recombinant human G-CSF (Lenograstim) 263 micro g/day SC starting either from day 12 (Group 1) or day 17 (Group 2). Fifty-five patients (41 male, 14 female) with a median age of 34 yea…
Aggressive chemotherapy combined with G-CSF and maintenance therapy with interleukin-2 for patients with advanced myelodysplastic syndrome, subacute …
1993
Aggressive chemotherapy of advanced myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) evolving from MDS, subacute AML and secondary AML has usually been associated with low complete remission (CR) rates, a high incidence of early death, and low disease-free survival. We therefore have initiated a phase-III trial of aggressive chemotherapy consisting of idarubicin, cytosine arabinoside, and VP-16 to improve the CR rate. Each chemotherapy cycle is followed by G-CSF to accelerate neutrophil recovery and to reduce the incidence of infections. Until now, 19 patients with high-risk AML have been entered. The CR rate is 47%, with only one death during induction. Patients achieving CR ar…
Intensive chemotherapy with idarubicin, ara-C, etoposide, and m-AMSA followed by immunotherapy with interleukin-2 for myelodysplastic syndromes and h…
2000
Intensive chemotherapy followed by treatment with interleukin-2 (IL-2) was evaluated in a prospective, randomized, multicenter trial including 18 patients with refractory anemia with excess of blasts in transformation (RAEB-T), 86 patients with acute myeloid leukemia (AML) evolving from myelodysplastic syndromes, and six patients with secondary AML after previous chemotherapy. Median age was 58 years (range: 18-76 years). Forty-nine patients (45%) achieved a complete remission (CR) after two induction cycles with idarubicin, ara-C, and etoposide, 52% of them aged/=60 years and 35% aged60 years (p=0.06). After two consolidation courses, patients were randomized to four cycles of either high-…
Investigator-initiated trials of targeted oncology agents: why independent research is at risk?
2010
Background: Drug development traditionally has relied upon the complementary contributions of clinicians and scientists at academic institutions and at pharmaceutical companies. Greater regulatory burdens, increased bureaucratic requirements, restricted reimbursement, and spiralling research and development costs are exerting pressure on the drug development pipeline. The result is a de-emphasis of exploratory research, particularly independent academic research, despite its proven value in identifying new drug targets and developing innovative cancer therapies. Design: An expert panel assembled by the Biotherapy Development Association-a nonprofit international forum for academic and indus…