Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:60 - Any
Updated:9/16/2018
Start Date:April 2013
End Date:April 2019
Contact:Paul Hamlin, MD
Phone:212-639-6143

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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.


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.
We found this trial at
7
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Paul Hamlin, MD
Phone: 212-639-6143
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Basking Ridge, New Jersey 07920
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Commack, New York 11725
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500 Westchester Avenue
Harrison, New York 10604
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Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
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Rockville Centre, New York 11570
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