Geriatric Assessment + Chemotherapy for Lymphoma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen ByPaul Hamlin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Subjects must be fluent in English

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

I am about to start a new chemotherapy treatment.

+4 more

Exclusion Criteria

Subjects must not be enrolled in a Phase I trial

Subjects scoring ≥11 on the BOMC will be excluded

Subjects must not have been previously enrolled in this study

+1 more

Participant Groups

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.

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.

Prednisone is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Prednisone for: