Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 201
- 试验地点
- 15
- 主要终点
- Toxicity Assessment
研究概览
简要总结
This study will evaluate the ability of a largely self-administered geriatric assessment (GA) to predict toxicity in non-Hodgkin Lymphoma (NHL) patients ≥60 years old receiving chemotherapy or chemoimmunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting the following criteria will be eligible for enrollment in the study (unless excluded):
- •≥60 years old
- •Pathologically confirmed NHL.
- •Must meet criteria for initiation of treatment; consisting of:
- •Aggressive histology, or
- •Indolent histology with one of the following markers of large tumor burden (67):
- •Any nodal or extranodal tumor mass ≥7cm in greatest dimension
- •≥3 nodal masses that are each ≥3 cm in greatest dimension
- •Systemic symptoms
- •Cytopenias (leukocytes <1 × 109/L and/or platelets ,100 × 109/L)
- •Substantial splenomegaly
- •Serous effusion (plural effusion or peritoneal ascites)
- •Orbital or epidural involvement
- •Ureteral compression
- •Leukemic phase (malignant cells ≥5 x 109/L)
- •Must be starting a new chemotherapy regimen (patients whose treatment regimen includes an immunomodulatory agent such as lenalidomide or small molecule targeted agents such as Ibrutinib or Idelelasib will be included in the study; patients being treated with a single agent monoclonal antibody will not be included).
- •Fluent in English (because not all components of the GA have been validated in other languages)
- •Able to provide informed consent
- •In addition to the above, subjects meeting the following criteria will be enrolled in the pre-phase arm of the study, until the accrual target for that arm is reached:
- •Age ≥ 70 years OR KPS ≤ 70
- •Pathologically confirmed diagnosis of DLBCL, with or without simultaneous or antecedent indolent lymphoma.
- •Previously untreated for DLBCL
- •Intended initial treatment to include ≥2 cycles of R-CHOP, R-EPOCH or R-CEPP using standard doses and schedule.(68, 69) R-CHOP chemoimmunotherapy may be given every 14 days or every 21 days. (4, 70)
排除标准
- •Subjects meeting the following criteria will be excluded from enrollment in the study:
- •Enrollment in a Phase I trial
- •Previously enrollment in this study
- •Patients scoring ≥ 11 on the BOMC (implying cognitive impairment) will be excluded since their ability to reliably complete the questionnaire will be in doubt Subjects meeting the following criteria will be excluded from enrollment in the pre-phase arm of the study, but may be included in the GA only arm.
- •Contraindication to use of rituximab or prednisone including:
- •Uncontrolled diabetes mellitus
- •Systemic fungal infection
- •Evidence of active hepatitis B infection (i.e. patients testing positive hepatitis B surface antigen or viral DNA by PCR analysis) will be excluded. Patients with evidence of past infection without active viremia (i.e. positive hepatitis B core antibody, negative hepatitis B surface antigen and negative hepatitis B DNA PCR) will be treated with entecavir as per institutional guidelines and may be included in the study.
- •History of any serious adverse reaction to either a corticosteroid or rituximab not including rituximab infusion reactions ≤ Grade
- •Patients enrolled on another clinical trial which prohibits the use of pre-phase therapy or any of its components.
研究组 & 干预措施
Geriatric Assessment (GA) only arm
Patients enrolled on the GA only arm of the study will be treated according to the choice of the attending physician. This arm of the study is non-therapeutic.
干预措施: Geriatric Assessment (Behavioral)
Pre-Phase Arm
They will be treated with a single dose of rituximab 375mg/m2, once, by intravenous infusion 3-10 days prior to initiation of planned R-CHOP-like chemoimmunotherapy, and prednisone 50mg to 100 mg (preferred dose is 100mg) PO daily for 5-7 days (preferred duration is 7 days) of the 14 days prior to initiation of planned R-CHOP, R-EPOCH or R-CEPP chemoimmunotherapy. Pre-phase therapy may be given in either the inpatient or outpatient setting. After completion of a single course of pre-phase rituximab and prednisone as described above, further treatment will be according to the choice of the attending physician, in accordance with appropriate medical practice. It is expected, based on the inclusion criteria, that patients enrolled on the pre-phase arm will most often receive initial therapy consisting of R-CHOP, R-EPOCH or RCEPP chemoimmunotherapy for ≥ 2 cycles, but alternative therapies as deemed appropriate by the treating physician will not be considered violations of this protocol.
干预措施: Geriatric Assessment (Behavioral)
Pre-Phase Arm
They will be treated with a single dose of rituximab 375mg/m2, once, by intravenous infusion 3-10 days prior to initiation of planned R-CHOP-like chemoimmunotherapy, and prednisone 50mg to 100 mg (preferred dose is 100mg) PO daily for 5-7 days (preferred duration is 7 days) of the 14 days prior to initiation of planned R-CHOP, R-EPOCH or R-CEPP chemoimmunotherapy. Pre-phase therapy may be given in either the inpatient or outpatient setting. After completion of a single course of pre-phase rituximab and prednisone as described above, further treatment will be according to the choice of the attending physician, in accordance with appropriate medical practice. It is expected, based on the inclusion criteria, that patients enrolled on the pre-phase arm will most often receive initial therapy consisting of R-CHOP, R-EPOCH or RCEPP chemoimmunotherapy for ≥ 2 cycles, but alternative therapies as deemed appropriate by the treating physician will not be considered violations of this protocol.
干预措施: rituximab (Drug)
Pre-Phase Arm
They will be treated with a single dose of rituximab 375mg/m2, once, by intravenous infusion 3-10 days prior to initiation of planned R-CHOP-like chemoimmunotherapy, and prednisone 50mg to 100 mg (preferred dose is 100mg) PO daily for 5-7 days (preferred duration is 7 days) of the 14 days prior to initiation of planned R-CHOP, R-EPOCH or R-CEPP chemoimmunotherapy. Pre-phase therapy may be given in either the inpatient or outpatient setting. After completion of a single course of pre-phase rituximab and prednisone as described above, further treatment will be according to the choice of the attending physician, in accordance with appropriate medical practice. It is expected, based on the inclusion criteria, that patients enrolled on the pre-phase arm will most often receive initial therapy consisting of R-CHOP, R-EPOCH or RCEPP chemoimmunotherapy for ≥ 2 cycles, but alternative therapies as deemed appropriate by the treating physician will not be considered violations of this protocol.
干预措施: prednisone (Drug)
结局指标
主要结局
Toxicity Assessment
时间窗: 3 years
Hospitalization during or within 30 days following chemotherapy Dose delay or reduction to a dose intensity ≤80% of the planned dose intensity. Dose reductions occurring prior to cycle 1 of chemotherapy will be counted as events. Discontinuation of chemotherapy due to toxicity Grade 3 or higher non-hematologic toxicity Grade 4 or higher hematologic toxicity. Using the NCI CTCAE v4.0 toxicity grading
次要结局
未报告次要终点