LLS Program Services for Blood Cancer

Recruiting at 2 trial locations

Overseen By Carlos A Melara

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Not receiving treatment, Participating in LLS, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the impact that the services and programs provided by the Leukemia and Lymphoma Society have among patients with blood cancer, such as access to care, quality of life, and financial burden.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment since the study focuses on the impact of services and programs, not on changing medical treatments.

What data supports the effectiveness of the LLS Program treatment for blood cancer?

The Leukemia & Lymphoma Society (LLS) enhances patient-centered care by educating patients and healthcare professionals about blood cancers, which can lead to better treatment choices and outcomes. Additionally, patient-reported outcomes (PROs) are used to assess treatment effectiveness and quality of life, providing valuable insights into the patient's perspective on their care. ^{1 2 3 4 5}

Is the LLS Program Services for Blood Cancer treatment generally safe for humans?

The treatment of blood cancers like non-Hodgkin lymphoma and chronic lymphocytic leukemia has improved, but safety concerns remain due to side effects like severe cytopenias (low blood cell counts) and unique toxicities from newer drugs. Many drugs for blood cancers have had safety-related changes after approval, including warnings about side effects, so it's important to be cautious and monitor for unrecognized side effects. ^{6 7 8 9 10}

How does the LLS Program Services for Blood Cancer treatment differ from other treatments for blood cancer?

The LLS Program Services for Blood Cancer treatment is unique because it may involve a comprehensive approach that includes induction, consolidation, and maintenance phases with central nervous system (CNS) prophylaxis, which is a preventive treatment to stop cancer from spreading to the brain and spinal cord. This approach is particularly important for advanced stages of blood cancer, where traditional chemotherapy has shown limited success. ^{11 12 13 14 15}

Research Team

Frank Penedo, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for blood cancer patients currently undergoing treatment who have unmet needs that the Leukemia and Lymphoma Society's (LLS) Program aims to address. Participants must speak English or Spanish, not be using LLS services already, and agree to a 6-month follow-up.

Inclusion Criteria

I need help with medical care, travel, trials, finances, or learning about my disease.

Not be currently participating in any LLS programs or services

I am currently being treated for leukemia, lymphoma, myeloma, MDS, or MPN.

Exclusion Criteria

I do not need help with medical care, travel, trials, finances, or education about my disease.

Are currently participating in any LLS programs or services

I am not willing to participate in follow-up for 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LLS services and/or standard care for 6 months

6 months

Baseline, 3 month, 6 month visits

Follow-up

Participants are monitored for changes in access to care, quality of life, and financial burden

3 months

Treatment Details

Interventions

• LLS Program

Trial Overview The study evaluates how the LLS Program affects blood cancer patients' access to care, quality of life, and financial burden. It seeks to understand if these services fill gaps in their current care regimen over a six-month period.

Participant Groups

Group I: LLS Program and Usual Care Group Experimental Treatment 1 Intervention

Participants in the LLS Program and Usual Care condition will receive LLS services such as information, services, and financial aid so that patients can have better access to healthcare and better quality of life. Participants will also receive the standard care. Participants will be in this group for 6 months.

Group II: Usual Care Group Active Control 1 Intervention

Participants will receive the standard care. Participants will be in this group for 6 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

Findings from Research

The Leukemia & Lymphoma Society (LLS) enhances patient-centered care for blood cancer patients by providing education and resources, empowering patients to make informed treatment choices throughout their care journey.

LLS also supports healthcare professionals through free educational seminars, improving their knowledge of blood cancers and best practices, which strengthens coordination between patients, caregivers, and medical staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States - The Leukemia & Lymphoma Society: Working with patients, carers and hospital professionals to improve awareness, treatment and patient choice. [2015]

Patient-reported outcomes (PROs) are crucial for understanding health outcomes as they provide direct insights into a patient's health status, symptoms, and quality of life, particularly in hematology and oncology settings.

Implementing PROs in clinical practice can enhance patient-physician communication and tailor therapies to individual needs, ultimately improving patient outcomes and the overall quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in clinical practice. Dobrozsi, S., Panepinto, J.[2016]

Patient-reported outcomes (PROs) are crucial for understanding treatment benefits from the patient's perspective, especially in hematologic clinical trials, as they provide insights into treatment effectiveness, toxicity, and overall well-being.

The FDA has established guidelines for PRO measures, emphasizing their importance in drug development, particularly when multiple treatment options yield similar survival outcomes, allowing for better clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in drug development for hematology. Acquadro, C., Regnault, A.[2021]

In the LRF CLL4 trial with over 10 years of follow-up, patients treated with fludarabine-plus-cyclophosphamide (FC) had significantly longer progression-free survival (PFS) compared to those on chlorambucil or fludarabine, but had shorter overall survival (OS) after progression.

Achieving a complete remission (CR) with second-line therapy significantly improved OS, especially for patients receiving FC-based treatments or stem cell transplants, highlighting the importance of effective salvage therapies in chronic lymphocytic leukaemia (CLL).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-term outcome of patients in the LRF CLL4 trial: the effect of salvage treatment and biological markers in those surviving 10 years. Else, M., Wade, R., Oscier, D., et al.[2018]

Implementing standardized criteria for palliative care (PC) consultations significantly increased the rate of early PC utilization among older patients with acute leukemia, from 55% to 80% during the intervention periods.

Despite the increase in early consultations, 43% of patients who received a PC consult did not have any follow-up encounters, indicating a need for improved strategies to ensure ongoing integration of PC with oncologic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Institution of Standardized Consultation Criteria to Increase Early Palliative Care Utilization in Older Patients With Acute Leukemia. Rosenblum, RE., Ormond, E., Smith, CW., et al.[2023]

Significant advancements in the treatment of haematological malignancies over the past two decades have led to improved 5-year survival rates for conditions like chronic myelogenous leukaemia and multiple myeloma, transforming many of these cancers into manageable chronic diseases.

The Commission emphasizes the need for better assessment of adverse events in clinical trials, advocating for the inclusion of patient-reported outcomes and addressing unique challenges in toxicity evaluation, particularly in the context of stem-cell transplantation and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. Thanarajasingam, G., Minasian, LM., Baron, F., et al.[2023]

Recent advancements in the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) have led to improved patient responses and survival rates, but adverse events remain a significant concern.

New targeted therapies are being developed that may reduce the hematologic toxicity seen with traditional chemotherapy, yet these newer agents also have unique toxicity profiles that require careful management and monitoring during clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accurate reporting of adverse events in chronic lymphocytic leukemia and non-Hodgkin lymphoma. Cheson, BD., Rai, KR., Friedberg, JW.[2012]

A review of 35 new drugs for hematological malignancies revealed that 80% had postmarketing safety-related label modifications, indicating that many drugs may have unrecognized side effects after approval.

Most of these drugs were approved based on limited evidence, with 77% not supported by randomized controlled trials, highlighting the need for caution among hematologists when prescribing these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies. Gafter-Gvili, A., Tibau, A., Raanani, P., et al.[2020]

Adverse event reporting in hematology clinical trials is currently done manually, leading to significant underreporting, especially in phase III trials, which can obscure the true safety profile of treatments for clinicians and patients.

Recent studies are exploring innovative methods, such as automated data extraction from electronic health records and alert systems, to improve the accuracy and comprehensiveness of adverse event reporting, enhancing our understanding of treatment toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery. Miller, TP., Aplenc, R.[2021]

The development of novel therapeutics for haematological malignancies has led to significant improvements in patient outcomes, but these new treatments come with unique adverse event profiles compared to traditional chemotherapy.

A Commission of experts has been actively working on enhancing the evaluation of adverse events and patient-reported outcomes related to these newer therapies, focusing on long-term toxicity and regulatory approval processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies. Thanarajasingam, G., Minasian, LM., Bhatnagar, V., et al.[2023]

In a study of 53 pediatric patients with lymphoblastic lymphoma over 14 years, only 31% achieved continuous complete remission, highlighting the challenges in treating advanced stages of the disease.

The chemotherapy regimen was effective for early-stage patients, but for those with advanced disease (stage IV), it was inadequate, indicating a need for protocol modifications similar to those used in high-risk childhood acute lymphoblastic leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lymphoblastic lymphoma in children. Poor response in advanced disease with chemotherapy for non-Hodgkin's lymphoma]. Rivera-Luna, R., Cárdenas-Cardós, R., Martínez-Avalos, A., et al.[2007]

The intensive modified NHL-BFM-90 program was successfully administered to 5 adult patients with poor-prognosis diffuse large B-cell lymphosarcoma (DLBCL), resulting in complete remission for all participants.

After a follow-up period of 6 to 20 months (median 13 months), none of the patients experienced recurrences, indicating the potential efficacy of the mNHL-BFM-90 treatment in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First experience of using modified program NHL-BFM-90 for the treatment of primary diffuse large-B-cell lymphosarcoma of the bones and soft tissues with poor-prognosis]. Morozova, AK., Zvonkov, EE., Kremenetskaia, AM., et al.[2009]

In a study of 30 patients with high-risk lymphoblastic lymphoma (LBL) who underwent autologous stem cell transplantation (ASCT), those treated with ALL-type regimens showed significantly better long-term outcomes, with a 5-year disease-free survival (DFS) and overall survival (OS) probability of 77.8%, compared to 22.2% for those treated with NHL-type regimens.

The overall estimated 5-year DFS and OS for all patients was 50.4% and 53.9%, respectively, indicating that intensive first-line treatment followed by ASCT can improve survival rates in high-risk LBL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical outcome of autologous stem cell transplantation as first-line treatment in 30 patients with high risk lymphoblastic lymphoma]. Huang, W., Zou, D., Sui, W., et al.[2014]

Allogeneic hematopoietic stem cell transplants (HSCT) were performed on 15 patients with B cell acute lymphocytic leukemia (ALL), showing potential effectiveness in treatment, with 9 patients surviving after follow-up periods of 2.5 to 65 months.

The study reported a significant incidence of graft versus host disease (GVHD), with 40% of patients experiencing extensive acute and chronic GVHD, highlighting the need for careful management of this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic hemopietic stem cell transplants for the treatment of B cell acute lymphocytic leukemia. Dong, WM., Cao, XS., Wang, B., et al.[2019]

The LSA2-L2 treatment protocol for children with non-Hodgkin's lymphoma resulted in a high complete remission rate of 95.8%, demonstrating its efficacy in managing this disease.

Relapse-free survival rates varied significantly by disease stage, with a 100% RFS in early stages (I-II) compared to 69% in advanced stages (III-IV), highlighting the importance of disease staging in predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood non-Hodgkin's lymphoma and "leukemia-lymphoma syndrome": long-term results with the modified LSA2-L2 protocol. Vecchi, V., Serra, L., Pession, A., et al.[2019]

References

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

United States - The Leukemia & Lymphoma Society: Working with patients, carers and hospital professionals to improve awareness, treatment and patient choice. [2015]

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

Patient-reported outcomes in clinical practice. [2016]

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

Patient-reported outcomes in drug development for hematology. [2021]

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

The long-term outcome of patients in the LRF CLL4 trial: the effect of salvage treatment and biological markers in those surviving 10 years. [2018]

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

Institution of Standardized Consultation Criteria to Increase Early Palliative Care Utilization in Older Patients With Acute Leukemia. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. [2023]

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

Accurate reporting of adverse events in chronic lymphocytic leukemia and non-Hodgkin lymphoma. [2012]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies. [2020]

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

Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery. [2021]

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

Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies. [2023]

11. Mexico pubmed.ncbi.nlm.nih.gov

[Lymphoblastic lymphoma in children. Poor response in advanced disease with chemotherapy for non-Hodgkin's lymphoma]. [2007]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[First experience of using modified program NHL-BFM-90 for the treatment of primary diffuse large-B-cell lymphosarcoma of the bones and soft tissues with poor-prognosis]. [2009]

13. China pubmed.ncbi.nlm.nih.gov

[Clinical outcome of autologous stem cell transplantation as first-line treatment in 30 patients with high risk lymphoblastic lymphoma]. [2014]

14. Thailand pubmed.ncbi.nlm.nih.gov

Allogeneic hemopietic stem cell transplants for the treatment of B cell acute lymphocytic leukemia. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Childhood non-Hodgkin's lymphoma and "leukemia-lymphoma syndrome": long-term results with the modified LSA2-L2 protocol. [2019]