scholarly journals Imatinib 800 mg daily induces deeper molecular responses than imatinib 400 mg daily: results of SWOG S0325, an intergroup randomized PHASE II trial in newly diagnosed chronic phase chronic myeloid leukaemia

2013 ◽  
Vol 164 (2) ◽  
pp. 223-232 ◽  
Author(s):  
Michael W. Deininger ◽  
Kenneth J. Kopecky ◽  
Jerald P. Radich ◽  
Suzanne Kamel-Reid ◽  
Wendy Stock ◽  
...  
Keyword(s):  
Chronic Myeloid Leukaemia ◽  
Myeloid Leukaemia ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Chronic Phase ◽  
Newly Diagnosed ◽  
Molecular Responses ◽  
Randomized Phase Ii

A randomized, phase II trial of adjuvant immunotherapy with durable TKI-free survival in patients with chronic phase CML

2021 ◽  
pp. 106737
Author(s):  
Jonathan A. Webster ◽  
Tara M. Robinson ◽  
Amanda L. Blackford ◽  
Erica Warlick ◽  
Anna Ferguson ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Chronic Phase ◽  
Free Survival ◽  
Adjuvant Immunotherapy ◽  
Randomized Phase Ii

NABTT 0306: A randomized phase II trial of EMD 121974 in conjunction with concomitant and adjuvant temozolomide with radiation therapy in patients with newly diagnosed glioblastoma multiforme (GBM)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2001-2001 ◽  
Author(s):  
L. B. Nabors ◽  
T. Mikkelsen ◽  
T. Batchelor ◽  
G. Lesser ◽  
M. Rosenfeld ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Survival ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Methylation Status ◽  
Newly Diagnosed ◽  
Integrin Receptor ◽  
Randomized Phase Ii ◽  
Newly Diagnosed Glioblastoma ◽  
Dose Levels

2001 Background: EMD 121974 (cilengitide) is a selective integrin receptor inhibitor that is well tolerated and has demonstrated biological activity in patients with malignant glioma. The objectives of this phase II trial were to determine safety when combined with chemoradiation and estimate the overall survival for two different doses in newly diagnosed GBM. Methods: A total of 112 patients were accrued onto the trial through the NABTT CNS consortium. Cilengitide was administered by one-hour infusion twice a week with 18 patients treated in a safety run-in phase of 6 patients at the tested dose levels of 500 mg, 1000 mg, and 2000 mg. After safety completion, 94 patients were randomly assigned to either 500 mg or 2000 mg groups. To date, 55 out of 112 (49%) patients have died. Overall survival was estimated using all patients in this trial regardless of their treating dose. Results: The median age was 55 years old (range: 22–88) and the median KPS was 90 (range: 60–100). 86 out of the 112 (76.8%) had a craniotomy as their initial surgical procedure and 25 patients (22%) had a biopsy. There were no DLTs during the safety run-in phase. The estimated median survival time is 18.9 months (95% CI: 16.3 -30.0 months) for patients treated with RT+TMZ+EMD. The trial was closed to accrual on December 31, 2007. To date, 89 out of 112 patients were alive 12 months from their initial diagnosis. The overall survival at 12 months for all patients is 79.5% (95% CI: 71–87%). MGMT methylation status and survival based on dose levels received are not currently available. Conclusions: EMD 121974 (cilengitide) is well-tolerated when combined with standard chemoradiation (TMZ+RT) and may improve survival for patients newly diagnosed with GBM given the substantial differences between the estimated median survival and that seen in the EORTC study (Stupp, N Engl J Med, 2005). [Table: see text]

Phase I/randomized phase II trial of either dasatinib or placebo combined with standard chemoradiotherapy for newly diagnosed glioblastoma multiforme (GBM): Final results of phase I study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 2032-2032 ◽  
Author(s):  
Nadia N. Laack ◽  
Evanthia Galanis ◽  
Clinton Leinweber ◽  
Jan C. Buckner ◽  
Caterina Giannini ◽  
...  
Keyword(s):  
Phase I ◽  
Dose Level ◽  
Phase Ii ◽  
Progressive Disease ◽  
Phase Ii Trial ◽  
Newly Diagnosed ◽  
Entire Study ◽  
Randomized Phase Ii ◽  
Level 1 ◽  
Grade 3

2032 Background: Dasatinib is a potent oral ATP competitive multi-targeted kinase inhibitor of multiple members of the Src kinase family, known to be involved in gliomagenesis and invasion. N0877 is a phase I/randomized phase II trial evaluating the combination of dasatinib, radiation (RT) and temozolomide (TMZ) in newly diagnosed GBM. The phase I portion has been completed and is the focus of this report. Methods: A cohorts-of-3 design was used to assess the safety of dasatinib in combination with RT and concomitant TMZ, and establish the phase II dose of the combination. Dasatinib was given orally for 42 days, beginning with the first day of RT (total dose 60 Gy) and first dose of TMZ (75 mg/m2/d). A 24 - 42 day rest (cycle 2) followed the RT/TMZ/dasatinib. Patients (pts) were observed for DLT to the end of cycle 2. Patients then received 6 cycles (28 day cycles) of dasatinib (once daily) and TMZ (days 1-5). At the completion of 6 cycles of TMZ + dasatinib, pts stay on dasatinib only (28 day cycles) until progressive disease. Results: Phase I component is complete with 13 patients (3 at dose level 0, 3 at dose level 0-A, 7 at dose level 1). One patient in dose level 1 had to be replaced due to the development of unrelated medical issues. One DLT (grade 4 pancytopenia) was observed in 1 patient at dose level 0 (50mg bid) and one DLT (grade 3 rash) was observed in 1 patient at dose level 1 (150mg qd). MTD of dasatinib was determined to be 150mg daily. Most common adverse events throughout the entire study period were hematologic with the most common toxicity being lymphopenia (grade 3 in 69% of patients, grade 4 in 8%). Other toxicities attributed to treatment and occurring in > 10% of patients included anemia (31%), neutropenia (15%), and fatigue(15%). Best response was stable disease in 10 patients, progressive disease in 1 patient, and not evaluable in 2. Conclusions: MTD for dasatinib in combination with TMZ and RT in newly diagnosed GBM patients is 150mg daily. Toxicity was primarily hematologic with minimal non-hematologic events. This dose is currently being used in the ongoing placebo-controlled, randomized phase II trial.

scholarly journals Long‐term data from a phase 3 study of radotinib versus imatinib in patients with newly diagnosed, chronic myeloid leukaemia in the chronic phase (RERISE)

2020 ◽  
Vol 189 (2) ◽  
pp. 303-312 ◽  
Author(s):  
Young Rok Do ◽  
Jae‐Yong Kwak ◽  
Jeong A. Kim ◽  
Hyeoung Joon Kim ◽  
Joo Seop Chung ◽  
...  
Keyword(s):  
Chronic Myeloid Leukaemia ◽  
Myeloid Leukaemia ◽  
Chronic Phase ◽  
Newly Diagnosed ◽  
Phase 3 ◽  
Term Data
Sign in / Sign up

Export Citation Format

Share Document