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Corticosteroid

Geriatric Assessment + Chemotherapy for Lymphoma

N/A

Waitlist Available

Led By Paul Hamlin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have pathologically confirmed NHL

Subjects must meet criteria for initiation of treatment based on aggressive or indolent histology with specific markers of large tumor burden, systemic symptoms, cytopenias, splenomegaly, serous effusion, orbital or epidural involvement, ureteral compression, or leukemic phase

Must not have

Subjects with contraindications to rituximab or prednisone, active hepatitis B infection, serious adverse reactions to corticosteroids or rituximab, or enrolled in another clinical trial prohibiting pre-phase therapy will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well a self-administered assessment can predict toxicity in older patients with NHL receiving chemotherapy.

Who is the study for?

This trial is for people aged 60 or older with non-Hodgkin Lymphoma who need to start chemotherapy. They must be fluent in English, able to consent, and not have severe cognitive impairment. Those over 70 or with a performance status score ≤70 may join an additional part of the study if they haven't been treated for diffuse large B-cell lymphoma.

What is being tested?

The study tests whether a self-administered geriatric assessment can predict treatment toxicity in older patients receiving chemo or chemoimmunotherapy. It includes a pilot study where some patients receive pre-phase therapy before standard treatments like R-CHOP.

What are the potential side effects?

Possible side effects include reactions related to rituximab infusion (which could range from mild to severe), complications from prednisone such as high blood sugar, infections due to immune system suppression, and other typical chemotherapy-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My diagnosis of non-Hodgkin lymphoma is confirmed by lab tests.

Select...

I need treatment for my cancer because it's spreading or causing symptoms.

Select...

I am 70 or older or have a low performance status, with untreated DLBCL, and plan to start specific chemotherapy.

Select...

I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have allergies or serious reactions to rituximab or prednisone, and I'm not in another trial that forbids pre-phase therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Toxicity Assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pre-Phase ArmExperimental Treatment3 Interventions

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.

Group II: Geriatric Assessment (GA) only armExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rituximab

2000

Completed Phase 3

~2760

prednisone

1999

Completed Phase 3

~10920