Geriatric Assessment + Chemotherapy for Lymphoma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a self-administered geriatric assessment can predict chemotherapy side effects in older adults with non-Hodgkin lymphoma, a type of blood cancer. It will evaluate treatments such as prednisone, a corticosteroid, and rituximab, a monoclonal antibody, administered before a standard chemotherapy regimen. Suitable candidates for this trial are individuals aged 60 or older with confirmed non-Hodgkin lymphoma, who experience symptoms like large tumor masses or systemic symptoms, and are about to begin a new chemotherapy plan. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance treatment strategies for older adults with non-Hodgkin lymphoma.

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 prior data suggests that this geriatric assessment is safe for predicting toxicity in lymphoma patients?

Research has shown that rituximab, often used with chemotherapy, is generally well-tolerated. Studies have found its safety comparable to other treatments. However, more than 10% of patients may experience infusion reactions, such as fever or chills.

Prednisone, a type of steroid, is also part of this treatment. It is commonly used and usually safe, but it can cause side effects like increased appetite, mood changes, or trouble sleeping. These side effects are often manageable and temporary.

Overall, while both rituximab and prednisone can cause side effects, healthcare professionals consider them safe for many patients, especially with proper monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines a tailored treatment approach with a focus on geriatric assessment for lymphoma patients. Unlike standard lymphoma treatments, which often follow a one-size-fits-all protocol, this trial explores how integrating a geriatric assessment can personalize treatment plans, potentially improving outcomes for older patients. The pre-phase treatment arm uses rituximab and prednisone in a specific pre-treatment regimen, which might better prepare patients for the intensive chemoimmunotherapy that follows. By customizing care based on individual health characteristics and treatment responses, this approach aims to optimize therapy effectiveness while minimizing side effects, offering a promising avenue for elderly patients who typically face higher treatment risks.

What evidence suggests that this trial's treatments could be effective for non-Hodgkin Lymphoma?

In this trial, one arm uses rituximab and prednisone before starting full chemoimmunotherapy. Studies have shown this approach can be very effective for treating non-Hodgkin lymphoma. Research indicates that 81% of patients live for at least five years without disease progression and have a high chance of survival. Specifically, another study found that this treatment combination led to a 92% success rate in shrinking or eliminating tumors. These results suggest rituximab and prednisone could be very promising for treating this type of lymphoma. Meanwhile, another arm of this trial involves a Geriatric Assessment only, where patients receive treatment based on the attending physician's choice. ^{5 6 7 8 9}

Who Is on the Research Team?

Paul Hamlin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34289656/

Prephase rituximab/prednisone therapy and aging ... - PubMed With a median follow-up of 4.4 years, both 5-year progression-free survival and overall survival were at 81% (95% confidence interval: 69-96).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2844047/

Impact of Rituximab (Rituxan) on the Treatment of B-Cell Non ... This combination was found to be very effective, with an ORR of 92%. Maintenance Therapy for Follicular Lymphoma. Some authors consider rituximab to be an ideal ...

3. riabni.com riabni.com/rheumatoid-arthritis/rituximab-biosimilar-efficacy

Rituximab Biosimilar Efficacy In PV Study 1, 14/38 (37%) patients in the non-U.S.-licensed rituximab + short term prednisone arm experienced treatment-related infections compared to 15/36 ( ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT403338

Evaluation of outcomes between rituximab-abbs and ... Results: 535 patients were enrolled; 240 patients received RP rituximab and 295 patients received rituximab-abbs. The median time of follow up was 730 days, or ...

5. haematologica.org haematologica.org/article/view/haematol.2021.278719

Prephase rituximab/prednisone therapy and aging-related, ... With a median follow-up of 4.4 years, both 5-year progression-free survival and overall survival were at 81% (95% confidence interval: 69-96).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38935234/

Outcomes of Rituximab-abbs versus Rituximab in Patients ... We demonstrated that rituximab-abbs was noninferior to rituximab in both effectiveness and safety among patients receiving R-CHOP for DLBCL in this study.

7. rituxan-hcp.com rituxan-hcp.com/ra/efficacy/safety-data.html

RA | Safety Data & Possible Side Effects | RITUXAN® (rituximab) Adverse reactions reported in ≥10% of patients treated with the Ritux 3 regimen* vs patients treated with prednisone monotherapy were infusion-related reactions ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/761140s000lbl.pdf

RIABNI (rituximab-arrx) injection, for intravenous use Based on human data, rituximab products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed in utero (see Clinical ...

9. aetna.com aetna.com/cpb/medical/data/300_399/0314.html

Rituximab - Medical Clinical Policy Bulletins This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and ...