Geriatric Assessment + Chemotherapy for Lymphoma

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Chemotherapy, Chemoimmunotherapy

Disqualifiers: Cognitive impairment, Uncontrolled diabetes, Active hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Varies

201 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be starting a new chemotherapy regimen to participate.

What data supports the effectiveness of the treatment Geriatric Assessment + Chemotherapy for Lymphoma?

Research shows that adding rituximab to chemotherapy regimens like CHOP improves outcomes for elderly patients with diffuse large B-cell lymphoma, suggesting that similar combinations could be effective. ^{1 2 3 4 5}

Is the combination of geriatric assessment and chemotherapy safe for elderly patients with lymphoma?

Studies show that adding rituximab to a reduced-dose chemotherapy regimen for elderly patients with lymphoma can improve outcomes and has a manageable safety profile. This combination has been found to be effective and generally safe, even in very old patients, although elderly patients may still experience some side effects. ^{2 6 7 8 9}

How is the geriatric assessment plus chemotherapy treatment for lymphoma unique?

This treatment is unique because it uses a comprehensive geriatric assessment (CGA) to tailor chemotherapy doses and combinations specifically for elderly patients with diffuse large B-cell lymphoma, aiming to balance treatment effectiveness with manageable toxicity. ^{10 11 12 13 14}

Research Team

Paul Hamlin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Phase Therapy

Participants receive a single dose of rituximab and prednisone for 5-7 days prior to initiation of planned chemoimmunotherapy

2 weeks

1 visit (in-person)

Treatment

Participants receive R-CHOP, R-EPOCH, or R-CEPP chemoimmunotherapy for at least 2 cycles

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including toxicity assessment

30 days post-chemotherapy

Treatment Details

Interventions

• Geriatric Assessment
• Prednisone
• Rituximab

Trial Overview 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.

Participant Groups

Group I: Pre-Phase Arm Experimental Treatment 3 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 arm Experimental Treatment 1 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:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in European Union as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in Canada as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

In a retrospective study of 11 elderly patients (median age 83) with diffuse large B-cell lymphoma (DLBCL) who were not suitable for standard R-CHOP treatment, 45% achieved a complete response and 27% a partial response to rituximab combined with low-dose trofosfamide.

The treatment showed promising safety with a 1-year overall survival rate of 54.5% and manageable toxicity, primarily leukopenia, suggesting that this combination could be a viable alternative for elderly patients with DLBCL who cannot tolerate more aggressive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose trofosfamide plus rituximab is an effective and safe treatment for diffuse large B-cell lymphoma of the elderly: a single center experience. Schelker, RC., Herr, W., Reichle, A., et al.[2019]

In a study of 435 patients with diffuse large B-cell lymphoma (DLBCL), the addition of rituximab to CHOP chemotherapy (R-CHOP) was associated with a reduced risk of central nervous system (CNS) relapse, showing a trend of 6.4% risk in R-CHOP patients compared to 9.7% in those treated with CHOP.

Rituximab significantly lowered the risk of CNS relapse (hazard ratio 0.45) and this benefit was even greater for patients who achieved a complete response (hazard ratio 0.18), indicating that R-CHOP is particularly effective in preventing CNS involvement in DLBCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for central nervous system relapse in patients with diffuse large B-cell lymphoma: the impact of the addition of rituximab to CHOP chemotherapy. Villa, D., Connors, JM., Shenkier, TN., et al.[2022]

In a pooled analysis of 150 patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma, those treated with R-EPOCH showed significantly better event-free survival (EFS) and overall survival (OS) compared to those receiving R-CHOP, particularly in patients with a CD4 count ≥100/μL.

Patients with CD4 counts <50/μL experienced a much higher rate of treatment-related deaths (37% vs 6%), indicating that lower immune function increases the risk of lethal toxicity during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of AIDS malignancy consortium trials evaluating rituximab plus CHOP or infusional EPOCH chemotherapy in HIV-associated non-Hodgkin lymphoma. Barta, SK., Lee, JY., Kaplan, LD., et al.[2022]

The R-VNCOP-B regimen, which includes rituximab and several other chemotherapy agents, showed high efficacy and manageable toxicity in treating an elderly patient with high-grade B-cell lymphoma, leading to rapid improvement and long-lasting complete remission.

This case study suggests that R-VNCOP-B could be a promising first-line treatment option for elderly patients with aggressive non-Hodgkin lymphoma, especially those who may not tolerate more intensive regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durable response after VNCOP-B and rituximab in an elderly patient with high-grade B-cell lymphoma. Cencini, E., Fabbri, A., Schiattone, L., et al.[2019]

In a study of 13 elderly patients (median age 79) with diffuse large B cell lymphoma, the combination of rituximab with CHOP or THP-COP resulted in a 54% complete response rate and a 62% two-year survival rate, indicating its efficacy in this age group.

The treatment was generally safe, although 69% of patients experienced bone marrow suppression, and infusion reactions occurred in 30.7%, which were manageable by adjusting the rituximab dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy and adverse effects of rituximab with CHOP or THP-COP in old-old and extremely old patients with diffuse large B cell lymphoma]. Kikukawa, M., Miyazaki, K., Kiuchi, A., et al.[2019]

In a phase II study involving 14 elderly patients (median age 85) with aggressive B-cell lymphomas, the combination of rituximab and bendamustine resulted in a 54% complete response rate and a median overall survival of 7.7 months.

The treatment showed low toxicity, with major side effects like neutropenia occurring in only 17% of patients, suggesting that this regimen could be a safer alternative for elderly patients who are not candidates for the more aggressive R-CHOP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of bendamustine in combination with rituximab as first-line treatment in patients 80 years or older with aggressive B-cell lymphomas. Weidmann, E., Neumann, A., Fauth, F., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Retrospective analysis of frontline treatment efficacy in elderly patients with diffuse large B-cell lymphoma. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Multicenter Phase 2 Study of Reduced-Dose CHOP Chemotherapy Combined With Rituximab for Elderly Patients With Diffuse Large B-Cell Lymphoma. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Low-dose trofosfamide plus rituximab is an effective and safe treatment for diffuse large B-cell lymphoma of the elderly: a single center experience. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for central nervous system relapse in patients with diffuse large B-cell lymphoma: the impact of the addition of rituximab to CHOP chemotherapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Combination of rituximab with chemotherapy in diffuse large B-cell lymphoma. Evaluation in daily practice before and after approval of rituximab in this indication. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Pooled analysis of AIDS malignancy consortium trials evaluating rituximab plus CHOP or infusional EPOCH chemotherapy in HIV-associated non-Hodgkin lymphoma. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Durable response after VNCOP-B and rituximab in an elderly patient with high-grade B-cell lymphoma. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[The efficacy and adverse effects of rituximab with CHOP or THP-COP in old-old and extremely old patients with diffuse large B cell lymphoma]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Phase II study of bendamustine in combination with rituximab as first-line treatment in patients 80 years or older with aggressive B-cell lymphomas. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Modulated chemotherapy according to modified comprehensive geriatric assessment in 100 consecutive elderly patients with diffuse large B-cell lymphoma. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical impact of comprehensive geriatric assessment in patients aged 80 years and older with diffuse large B-cell lymphoma receiving rituximab-mini-CHOP: a single-institute retrospective study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Current treatment options for aggressive non-Hodgkin lymphoma in elderly and frail patients: practical considerations for the hematologist. [2021]

13. Italy pubmed.ncbi.nlm.nih.gov

Prephase rituximab/prednisone therapy and aging-related, proinflammatory cytokine milieu in older, vulnerable patients with newly diagnosed diffuse large B-cell lymphoma. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Treatment of the elderly patient with diffuse large B cell lymphoma. [2019]