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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01829958
First received: April 8, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Non Hodgkin Lymphoma (NHL)
Diffuse Large B-cell Lymphoma (DLBCL)
Drug: rituximab
Drug: prednisone
Behavioral: Geriatric Assessment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Toxicity Assessment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: rituximab Drug: prednisone Behavioral: Geriatric Assessment
Experimental: 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.
Behavioral: Geriatric Assessment

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829958

Contacts
Contact: Paul Hamlin, MD 212-639-6143
Contact: Andrew Zelenetz, MD, PhD 212-639-2656

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Paul Hamlin, MD    212-639-6143      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Paul Hamlin, MD    212-639-6143      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Paul Hamlin, MD    212-639-6143      
Contact: Andrew Zelenetz, MD, PhD    212-639-2656      
Principal Investigator: Paul Hamlin, MD         
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Paul Hamlin, MD    212-639-6143      
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Paul Hamlin, MD    212-639-6143      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Paul Hamlin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01829958     History of Changes
Other Study ID Numbers: 13-028
Study First Received: April 8, 2013
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Geriatric
Toxicity
rituximab
prednisone
Comprehensive Geriatric Assessment (CGA)
13-028

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Rituximab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014