AzTrials
AzTrials

Non Hodgkin Lymphoma (NHL)NCT01829958

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

A study testing rituximab, prednisone and Geriatric Assessment in people with Non Hodgkin Lymphoma (NHL) and Diffuse Large B-cell Lymphoma (DLBCL), run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
rituximab, prednisone and Geriatric Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
8 sitesUnited States
Study dates
Apr 2013to Apr 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 23Show fewer
  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York, 11570

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

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.

Being tested
rituximab, prednisone, Geriatric Assessment
Keywords
Geriatric, Toxicity, rituximab, prednisone, Comprehensive Geriatric Assessment (CGA), 13-028
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01829958
Study groupRoleWhat they receive
Pre-Phase ArmExperimentalThey 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.
Receives: Drug: rituximab; Drug: prednisone; Behavioral: Geriatric Assessment
Geriatric Assessment (GA) only armExperimentalPatients 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.
Receives: Behavioral: Geriatric Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829958
Sponsor's protocol ID
13-028
Status last verified
Sep 2026
First submitted
8 Apr 2013
Last updated
21 Sep 2026
Results posted
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in