Clinical trial NCT01829958: Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy
Official title: Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non Hodgkin Lymphoma (NHL)
Diffuse Large B-cell Lymphoma (DLBCL)
Keywords: Geriatric
Toxicity
rituximab
prednisone
Comprehensive Geriatric Assessment (CGA)
13-028
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 201
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Toxicity Assessment
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Hamlin, MD
role: PRINCIPAL_INVESTIGATOR
References: