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

Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01829958
• Other study ID #: 13-028
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma (NHL)

Intervention

Drug:
• rituximab

• prednisone

Behavioral:
• Geriatric Assessment

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity Assessment	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	3 years

External Links

•   Memorial Sloan Kettering Cancer Center