Intergroup study in elderly patients with AML to compare complete remission rate and overall survival after intermediate-dose or low-dose AraC.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 6618-6618
Author(s):  
T. Lange ◽  
D. Niederwieser ◽  
V. Hoffmann ◽  
M. Pfirrmann ◽  
G. Maschmeyer ◽  
...  
Keyword(s):  
Overall Survival ◽  
Complete Remission ◽  
Elderly Patients ◽  
Low Dose ◽  
Remission Rate ◽  
Complete Remission Rate ◽  
Intermediate Dose

The Reduction of Leukemic Blasts in Bone Marrow Aspirate on Day 6 of Remission Induction Treatment Is Predictive for Complete Remission Rate and Survival in Adult Acute Myeloid Leukemia; the Results of Multicenter, Prospective Polish Adult Leukemia Group Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4375-4375
Author(s):  
Jerzy Holowiecki ◽  
Sebastian Grosicki ◽  
Slawomira Kyrcz-Krzemien ◽  
Kazimierz Kuliczkowski ◽  
Marek Kielbinski ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Overall Survival ◽  
Complete Remission ◽  
Remission Rate ◽  
Prospective Trial ◽  
Complete Remission Rate ◽  
Remission Induction ◽  
Induction Treatment ◽  
Early Evaluation ◽  
Bone Marrow Specimen

Abstract The goal of this study was to prove the significance of an early evaluation of leukemic blast reduction based on cytological examination of bone marrow aspirates obtained on day 6 of remission induction treatment. Patients. 90 adult AML patients aged 18–60 (median 47) registered to the PALG prospective trial evaluating the efficacy of 3 remission induction protocols: DAF: daunorubicine (DNR) 60 mg/m2/d iv, d 1–3; cytarabine (AraC) 200 mg/m2/d ci, d 1–7, and fludarabine 25 mg/m2 2h inf. iv d 1–5), DAC (like DAF but cladribin is used at 5 mg/m2 instead of fludarabine) and the standard DA 3+7 regimen. Bone marrow aspirates were performed before the treatment and on the 6-th day of the first remission induction course, and the MGG stained marrow smears were evaluated at each centre by two experienced hematologists. Results. Based on the proportion of blasts in bone marrow specimen on day 6 patients were arranged into 2 groups: “responders”with ≤5% of blasts (n=59) and “non responders” with >5% of myeloblasts in bone marrow (n=31). The complete remission rate (CR) in the first group equalling 89% (51/59) was significantly higher in comparison to that obtained in the second group 29%(9/31), p=0,008. The probability of overall survival (OS) was also higher in the group of “responders” if compared to “non responders”; 65% versus 45% respectively, p=0,009. In multivariate analysis including bone marrow examination, cytogenetic risk group, age, leukocyte count at diagnosis and the induction arm only the persistence of leukemic blasts >5% in bone marrow specimen on 6-th day of induction was associated with higher risk of not achieving CR (HR = 52,6; p=0,00002), and with shorter OS (HR=3,13; p=0,02). Conclusion. This prospective, multicenter study demonstrates that a simple and commonly accessible evaluation of the leukemic blasts reduction in bone marrow smear on the 6-th day of remission induction treatment is a reliable and independent predictor for achieving CR and for overall survival. This offers a decision point for an early modification of the treatment strategy.

The Reduction of Leukemic Blasts In Bone Marrow Aspirate on Day 6 of Remission Induction Treatment Is Predictive for Complete Remission Rate and Survival in Adult Acute Myeloid Leukemia: The Results of Multicenter, Prospective Polish Adult Leukemia Group Study.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1950-1950
Author(s):  
Jerzy Holowiecki ◽  
Sebastian Grosicki ◽  
Slawomira Kyrcz-Krzemien ◽  
Kazimierz Kuliczkowski ◽  
Marek Kielbinski ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Overall Survival ◽  
Complete Remission ◽  
Remission Rate ◽  
Prospective Trial ◽  
Bone Marrow Examination ◽  
Complete Remission Rate ◽  
Remission Induction ◽  
Induction Treatment ◽  
Early Evaluation

Abstract The goal of this study was to pr ove the significance of an early evaluation of leukemic blast reduction based on cytological examination of bone marrow aspirates obtained on day 6 of remission induction treatment. Patients: 152 adult AML patients aged 18–60 (median 47) registered to the PALG prospective trial evaluating the efficacy of 3 remission induction protocols: DAF: daunorubicine (DNR) 60 mg/m2/d iv, d 1–3; cytarabine (AraC) 200 mg/m2/d ci, d 1–7, and fludarabine 25 mg/m2 2h inf. iv d 1–5) DAC (like DAF but cladribin is used at 5 mg/m2 instead of fludarabine) and the standard DA 3+7 regimen. Patients achieving CR received two courses of subsequent intensive consolidation: HAM (HD AraC, mitoxantrone) HD AraC. In case of partial remission (PR) after the first induction course the same regimen was repeated. Patients with no remission (NR) or with PR after 2 induction courses were withdrawn from the study. Bone marrow aspirates were performed before the treatment and on the 6-th day of the first remission induction course, and the MGG stained marrow smears were evaluated at each centre by two experienced hematologists. Results: Based on the proportion of blasts in bone marrow specimen on day 6 patients were arranged into 2 groups: “responders” with <5 % of blasts (n=59) and “non responders” with >5% of blastic cells in bone marrow (n=31). The complete remission rate (CR) in the “responders” group equaling 86% (82/95) was significantly higher in comparison to that found in the “non responders” group 33%(19/57), p=<0,00001. The probability of overall survival (OS) was also higher in the group of “responders” if compared to “non responders” one; 63% versus 33% respectively, p=0,0009. In multivariate analysis including bone marrow examination, cytogenetic risk group, age, leukocyte count at diagnosis and the induction arm, only the persistence of leukemic blasts >5% in bone marrow specimens on 6-th day of induction was associated with higher risk of not achieving CR (HR = 51,1; p=0,00002), and with shorter OS (HR=2,9; p=0,004). Conclusion: This prospective, multicenter study demonstrates that a simple and commonly accessible evaluation of the leukemic blasts reduction in bone marrow smear on the 6-th day of remission induction treatment is a reliable and independent predictor for achieving CR and for overall survival. This offers a decision point for an early modification of the treatment strategy.

Effect of anti-CD19 BiTE blinatumomab on complete remission rate and overall survival in adult patients with relapsed/refractory B-precursor ALL.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6500-6500 ◽  
Author(s):  
Max Topp ◽  
Nicola Goekbuget ◽  
Gerhard Zugmaier ◽  
Andreas Viardot ◽  
Matthias Stelljes ◽  
...  
Keyword(s):  
Overall Survival ◽  
Complete Remission ◽  
Residual Disease ◽  
Remission Rate ◽  
Day Treatment ◽  
Adult Patients ◽  
Complete Remission Rate ◽  
Target Cells ◽  
Partial Recovery ◽  
Final Dose

6500^ Background: Blinatumomab is a bispecific T-cell engaging (BiTE) antibody that directs cytotoxic T-cells to CD19 expressing target cells. Methods: In adult patients with relapsed/refractory B-precursor ALL, a phase II dose ranging trial is being conducted to evaluate efficacy and safety of blinatumomab. The primary endpoint is the rate of hematological complete remission (CR) or CR with partial hematological recovery (CRh*) within 2 cycles of blinatumomab treatment. Blinatumomab is administered by continuous intravenous infusion for 28-days followed by a 14-day treatment-free interval. Responding patients can receive 3 additional cycles of treatment or proceed to bone marrow transplantation. Three dose levels were explored as shown in the table. Results: In total 36 patients have been enrolled, 25 are currently evaluable. Seventeen out of 25 treated patients (68%) reached a hematological CR/CRh* and a minimal residual disease (MRD) response (MRD level <10-4) within the first 2 cycles. Five out of 17 responders (29%) showed a CRh* due to partial recovery of platelets. For the first 18 patients, response duration is 7.1 months and the median follow-up time for overall survival (OS) is 9.7 months (median not reached). Six cases of relapses have been recorded of which 3 were CD19+, and 3 CD19-. As final dose 5 µg/m²/day in week 1 and 15 µg/m²/day for the remaining treatment (cohort 2a and 3) was selected. In these cohorts (n=12), the most common treatment emergent adverse events (TEAEs, all grade 1-2) were pyrexia (67%), headache (33%) and tremor (33%). TEAEs of grade ≥3 (7 in 5 patients, no grade 4), irrespective of relationship, were infections, confusion, epilepsy, hypertension and thrombocytopenia. Conclusions: The final dose was well-tolerated and produced an exceptionally high complete remission rate. A global phase 2 study to confirm these data is underway. [Table: see text]

Clinical significance of immunophenotype in diffuse aggressive non-Hodgkin's lymphoma.

1989 ◽  
Vol 7 (12) ◽  
pp. 1783-1790 ◽  
Author(s):  
J O Armitage ◽  
J M Vose ◽  
J Linder ◽  
D Weisenburger ◽  
D Harrington ◽  
...  
Keyword(s):  
Overall Survival ◽  
T Cell ◽  
Complete Remission ◽  
B Cell ◽  
Clinical Significance ◽  
Cell Lymphoma ◽  
Remission Rate ◽  
Stage Iv ◽  
Stage I ◽  
Complete Remission Rate

We performed a prospective study of the clinical significance of immunophenotype in 110 patients with aggressive non-Hodgkin's lymphoma (NHL) treated by oncologists in the Nebraska Lymphoma Study Group between October 1982 and May 1986. All patients were immunophenotyped from biopsies performed before therapy was administered. The patients were treated with a uniform protocol of radiotherapy for minimal nonbulky, stage I or II disease (seven patients) or a single, six-drug chemotherapy regimen cyclophosphamide, doxorubicin, procarbazine, bleomycin, vincristine, and prednisone (CAP-BOP) in patients with more extensive disease (103 patients). Ninety-one patients (83%) had B-cell lymphoma and 19 patients (17%) had T-cell lymphoma. The histologic diagnosis of diffuse mixed-cell lymphoma was significantly associated with T-cell immunophenotype (45% v 5%; P less than .001), and the diagnosis of diffuse large-cell lymphoma was significantly associated with B-cell immunophenotype (40% v 5%; P = .006). However, no significant difference in frequency of prognostic variables such as age, stage, systemic symptoms, tumor bulk, serum lactic dehydrogenase, or performance status was found between the B-cell and T-cell groups. Patients with B-cell NHL had a slightly higher complete remission rate (74% v 53%; P = NS), similar durability of complete remission (75% v 70% at 3 years; P = NS), and a slightly but not significantly better overall survival (50% v 41% at 3 years; P = NS). The slight advantage in response rate and survival for B-cell patients was related to a very poor outcome for patients with stage IV T-cell NHL. For patients with stage I to III disease, neither the complete remission rate (B-cell, 82% v T-cell, 91%; P = NS) nor overall survival (3-year survival for B cell, 58% v T cell, 73%; P = NS) were significantly different. However, with stage IV disease B-cell patients fared far better than those with T-cell NHL for both complete remission rate (67% v 0%; P = .002) and overall survival (3-year survival, 44% v 0%; P = .002). Immunophenotyping intermediate- and high-grade NHL allowed identification of a subgroup of patients who had a very poor prognosis with this treatment approach and for whom alternate therapy might be considered.

High-Dose Mitoxantrone-Based Induction Therapy in Newly-Diagnosed AML. Results of 171 Patients Treated at NYMC between 1991–2003.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1859-1859
Author(s):  
Karen Seiter ◽  
Delong Liu ◽  
Eric Feldman ◽  
Qiuhu Shi ◽  
Paul Baskind ◽  
...  
Keyword(s):  
Overall Survival ◽  
Complete Remission ◽  
Median Duration ◽  
Induction Therapy ◽  
Remission Rate ◽  
Complete Remission Rate ◽  
High Dose ◽  
Newly Diagnosed ◽  
Once Daily ◽  
Duration Of Response

Abstract We developed a high dose mitoxantrone-based induction regimen based on the steep dose-response curve for mitoxantrone. Currently we report long-term results of the treatment of patients with newly-diagnosed AML with a single high dose of mitoxantrone combined with once daily cytarabine. One-hundred sixty-five patients treated on four studies of high-dose mitoxantrone-based induction therapy are included. Study 1: Phase II study, age <60. Induction: mitoxantrone 80 mg/m2 x 1, ara-C 3 gm/m2/d x 5, VP-16 150 mg/m2/d qod x 3. Consolidation: 5 mos ara-C x 4d with mitoxantrone 20 mg/m2 months 3 + 5, and with VP-16 150 mg/m2 x 2 months 4 + 6. Study 2: randomized study of high vs standard dose mitoxantrone with ara-C in pts ≥ 60 yrs. Pts did not receive consolidation. Only pts with high dose mitoxantrone are included here. Study 3: Same as study 1 except pts received ATRA 45 mg/m2 x 3 doses. Pts < 60 received consolidation as in study 1. Pts ≥ 60 did not receive consolidation. Study 4: Pts ≥ 60 yrs, same as study 2 + temozolomide postremission therapy. In each study, pts with prior antecedent hematologic disorder (AHD) or secondary AML were included. Median age: 59 (21–88); M/F: 91/80; cytogenetics(SWOG): good:13%, intermediate:50%, poor:26%, indeterminate:5%, IM:6%; Prior AHD: 32% of pts. The median follow up time is 65.9 months (95% CI: 55.7–86.2 months). The overall complete remission rate was 64%, with responses in 78% of patients less than 60 years of age and 52% of patients 60 years of age or older. The median duration of response is 21.2 months and 8.0 months, and overall survival is 15.4 months and 7.6 months, respectively. For a subset of patients who would be eligible for most US trials, the complete remission rate was 84% in younger patients and 60% in older patients. The median duration of response was 39.0 months and 8.2 months, and the median overall survival was 19.4 months and 7.6 months, respectively. Prospective analysis of secondary cytogenetic abnormalities showed such changes in 9 patients. Three of these were at the time of relapse, 3 had spontaneous resolution of these abnormalities, and 3 had MDS that evolved to AML. Two of the latter patients had Neurofibromatosis Type-1. Asymptomatic decreases in ejection fraction were common, however only 2 patients developed clinically significant cardiac dysfunction. The efficacy of these regimens compared favorably to results reported with standard “3+7” regimens. Use of a once-daily cytarabine regimen resulted in almost no neurotoxicity and allowed for administration of consolidation in the outpatient setting.

Sirolimus for patients with connective tissue disease-related refractory thrombocytopenia: a single-arm, open-label clinical trial

Rheumatology ◽  
2020 ◽  
Author(s):  
Chanyuan Wu ◽  
Qian Wang ◽  
Dong Xu ◽  
Mengtao Li ◽  
Xiaofeng Zeng
Keyword(s):  
Complete Remission ◽  
Connective Tissue ◽  
Connective Tissue Disease ◽  
Remission Rate ◽  
Complete Remission Rate ◽  
Severe Side Effect ◽  
Open Label ◽  
First Line Therapy ◽  
Primary Endpoints ◽  
Significant Difference

Abstract Objectives Connective tissue disease-related thrombocytopenia (CTD-TP) is a problematic disorder in clinical practice. Because the first-line therapy of glucocorticoid and/or immunosuppressants is not effective for refractory cases, alternative treatment approaches are urgently needed. The present study investigated the efficacy and safety of sirolimus in refractory CTD-TP patients. Methods This single-centre, single-arm, phase II study enrolled 20 refractory CTD-TP patients between September 2017 and September 2018 (registered on ClinicalTrials.gov: NCT03688191). Oral sirolimus administration was dose-adjusted to maintain a therapeutic range of 6–15 ng/ml for 6 months. The primary endpoints were partial and complete remission rates at 6 months. Results Twelve (60%) patients achieved the primary end point with a 50% complete remission rate after 6 months. Among the 14 SLE patients, the overall response rate was 71.4%, with a complete remission rate of 64.3%. None of the primary Sjögren's syndrome cases responded to sirolimus. There was no significant difference in baseline clinical characteristics or lymphocyte subpopulations between responders and non-responders. No severe side effect was detected during the study. Conclusion Sirolimus is an effective and safe treatment option for refractory CTD-TP patients. Trial registration https://clinicaltrials.gov, NCT03688191.

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