A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Successful Mobilization and Collection of PBSCs
研究概览
简要总结
This phase II trial is studying how well giving bendamustine hydrochloride, etoposide, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving chemotherapy, such as bendamustine hydrochloride, etoposide, and dexamethasone, before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored
详细描述
PRIMARY OBJECTIVES:
I. To estimate the frequency of bendamustine (bendamustine hydrochloride) combined with GCSF (filgrastim) and dexamethasone to successfully mobilize peripheral blood stem cells (PBSCs) (as determined by collecting a minimum of 2 x 10^6 cluster of differentiation (CD)34+/kg).
SECONDARY OBJECTIVES:
I. To evaluate the response rate to bendamustine by diagnosis using established disease-specific response criteria.
II. To examine the number of apheresis cycles required to collect a minimum of 2 x 10^6 CD34+ cells/kg and ideally >= 5 x 10^6 CD34+ cells/kg (when achievable).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin lymphoma), or multiple myeloma; other transplant eligible diagnoses (e.g. germ cell tumor) can be included with principal investigator (PI) approval
- •World Health Organization (WHO) classification of patients' malignancies must be provided
- •Patients with lymphoid malignancies must have a computed tomography (CT) of chest, abdomen, and pelvis within six weeks of enrollment; patients with evidence of lymphadenopathy in the neck must have a CT of neck
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Absolute neutrophil count (ANC) >= 1,500/mm^3
- •Platelets >= 100,000/mm^3 (without transfusion or growth factor support)
- •Creatinine clearance (CrCl) greater than 50/ml per minute (all tests must be performed within 28 days prior to registration)
- •Total bilirubin < 1.5 times upper limit of normal
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal
- •All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
- •Adequate venous access plan in place for apheresis procedure
- •Three or fewer prior myelotoxic treatment regimens (specific regimens include ifosfamide, carboplatin and etoposide [ICE]; cisplatin, cytarabine, and dexamethasone [DHAP]; methotrexate [MTX]/high-dose cytarabine [HiDAC]; cyclophosphamide, vincristine, doxorubicin, and dexamethasone [hyperCVAD]; bortezomib, thalidomide, dexamethasone and 4-day continuous infusions of cisplatin, doxorubicin, cyclophosphamide, and etoposide [VTD-PACE])
排除标准
- •Patients known positive for human immunodeficiency virus (HIV), or infectious hepatitis type B or C
- •Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- •Greater than six prior cycles of lenalidomide therapy
- •Patients who have previously demonstrated resistance to bendamustine therapy (i.e. no response or progression w/in 6 months)
- •Fludarabine or other nucleoside analog (except gemcitabine or cytarabine) therapy within 24 months of registration; patients with limited exposure to fludarabine/other nucleoside analog therapy within 24 months may be considered eligible with review and approval by the PI or Co-PI prior to study entry
- •Symptomatic cardiopulmonary disease
- •Prior autologous or allogeneic transplantation
- •Prior radioimmunotherapy within 12 weeks of registration
- •Prior failed (< 5 x 10^6 CD34/kg) PBSC collection due to inability to mobilize stem cells
- •Prior pelvic or spinal irradiation
- •Previous systemic chemotherapy/immunotherapy within 3 weeks before study entry
- •Concurrent use of other anti-cancer agents or experimental treatments
- •Known allergy or intolerance to bendamustine, mannitol, GCSF or dexamethasone
- •More than 3 cycles of myelotoxic salvage chemotherapy within the past 4 months (specific regimens include ICE, DHAP, MTX/HiDAC, hyperCVAD, VTD-PACE)
研究组 & 干预措施
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: bendamustine hydrochloride (Drug)
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: dexamethasone (Drug)
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: filgrastim (Biological)
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: leukapheresis (Procedure)
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: laboratory biomarker analysis (Other)
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: flow cytometry (Other)
Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
.
干预措施: etoposide (Drug)
结局指标
主要结局
Successful Mobilization and Collection of PBSCs
时间窗: Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride
Count of participants with successful mobilization and collection of PBSCs. Defined as collection of \> 2 x 10\^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.
次要结局
未报告次要终点
研究者
Ajay Gopal
Principal Investigator
University of Washington