Modified BFM-95 Regimen for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults:a Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to modified BFM-95 regimen for acute lymphoblastic leukemia.
详细描述
All patients received a modified BFM regimen which was derived from the NHL-BFM-95. The differences were as follows: (1) during the course of high-dose methotrexate therapy (HD-MTX), citrovorum folinate (CF) was used for rescue at 36 h after the administration of HD-MTX;(2) Pirarubicin was used instead of daunorubicin (3) Pegaspargase was used instead of L-asparaginase for patients.All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. CNS-positive patients received two additional doses of intrathecal MTX at days 18 and 27 of induction and received CRT after reinduction therapy. The dose was 18 Gy.Patients with identifiable blasts in CSF-cytospin preparation but less than 5cells/uL in CSF were not considered CNS positive but received two additional doses of intrathecal MTX at days 18 and 27. For men with testicular involvement,orchiectomy was not performed, and irradiation (20 Gy) of testes was to be confined to biopsy-proven persistent infiltration of testis after protocol M.Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosedT-LBL
- •age:18-65years
- •Ann Arbor stage IEto stage IVE
- •at lease one measurable lesion
- •receive no chemotherapy or radiotherapy before
- •Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
排除标准
- •mismatch the inclusion criteria
- •systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
研究组 & 干预措施
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: induction phase1 (Drug)
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: induction phase2 (Drug)
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: protocol M (Drug)
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: maintenance therapy (Drug)
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: reinduction phase1 (Drug)
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: reinduction phase2 (Drug)
Modifed BFM-95
All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.
干预措施: Intrathecal (IT) (Drug)
结局指标
主要结局
progression free survival
时间窗: up to end of follow-up-phase (approximately 3 years)
次要结局
- complete remission rate(every 4 weeks,up to completion of induction treatment(approximately 2months))
- overall survival(up to end of follow-up-phase (approximately 3 years))
- safety, including hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)(up to end of follow-up-phase (approximately 3 years))
研究者
Hua Wang
Professor
Sun Yat-sen University