Diffuse Large B-cell Lymphoma (DLBCL), Non Hodgkin Lymphoma (NHL)
Conditions
Keywords
Geriatric, Toxicity, rituximab, prednisone, Comprehensive Geriatric Assessment (CGA), 13-028
Brief summary
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.
Interventions
DRUGrituximab
DRUGprednisone
BEHAVIORALGeriatric Assessment
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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 3. * Patients enrolled on another clinical trial which prohibits the use of pre-phase therapy or any of its components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Assessment | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaul Hamlin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed