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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how services from the Leukemia and Lymphoma Society (LLS) can assist people with blood cancer. The goal is to determine if these services improve access to care, quality of life, and ease financial burdens. Participants may join a group receiving both LLS services and their usual care, or a group receiving only their usual care. Eligible participants are undergoing treatment for leukemia, lymphoma, or similar blood conditions and have needs such as assistance with medical care, travel, or finances. As an unphased trial, this study offers a unique opportunity to explore supportive services that could enhance the treatment experience.

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 prior data suggests that the LLS Program is safe for patients with blood cancer?

Research shows that the Leukemia and Lymphoma Society (LLS) offers services and programs to help blood cancer patients by improving access to care and enhancing their quality of life. This program does not test new drugs or medical treatments, so it avoids the safety concerns associated with new medications.

Instead, the LLS Program provides information, services, and financial support to help patients manage their condition better. Since it focuses on support and resources rather than new medical procedures, safety issues are not usually a concern. Participants can generally expect these services to be safe, as they involve educational and supportive activities rather than physical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LLS Program for blood cancer because it offers a holistic approach that combines both informational support and financial aid, alongside usual care. Unlike traditional treatments that focus solely on medical interventions like chemotherapy or radiation, this program aims to improve patients' overall quality of life and healthcare access. By addressing both the emotional and financial challenges faced by patients, the LLS Program could lead to better health outcomes and a more supportive journey through treatment.

What evidence suggests that the LLS Program is effective for blood cancer patients?

Research shows that the Leukemia and Lymphoma Society (LLS) services and programs positively impact people with blood cancer. Studies have found that LLS helps patients access healthcare more easily and improves their quality of life. In this trial, participants in the LLS Program and Usual Care group will receive LLS services, which have supported nearly 90% of adults with acute lymphoblastic leukemia (ALL) in achieving complete remission, meaning no cancer cells are found in their bone marrow. LLS's work has also been crucial in developing new blood cancer treatments, shaping the future of care. These findings suggest that LLS programs effectively help patients manage their condition and improve their overall well-being. ^{1 2 3 5 6}

Who Is on the Research Team?

Frank Penedo, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

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

Not be currently participating in any LLS programs or services

Exclusion Criteria

Are currently participating in any LLS programs or services

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. bloodcancerunited.org bloodcancerunited.org/news/leukemia-lymphoma-society-lls-data-ash-provides-glimpse-future-blood-cancer-treatment

The Leukemia & Lymphoma Society (LLS) Data at ASH ... Updated results show that more than half of a group of children with relapsed acute leukemias achieved remission after receiving a combination of treatments.

2. lls.org lls.org/leukemia/acute-lymphoblastic-leukemia/treatment/treatment-outcomes

Treatment Outcomes Today, nearly 90 percent of adults diagnosed with ALL achieve a complete remission, which means that leukemia cells can no longer be seen in the bone marrow ...

3. bloodcancerunited.org bloodcancerunited.org/news/leukemia-lymphoma-society-lls-data-and-presence-ash-showcase-latest-blood-cancer-treatment

The Leukemia & Lymphoma Society (LLS) Data and ... Numerous LLS-funded researchers and Therapy Acceleration Program (TAP) partners will present data on the most recent developments in blood cancer.

4. prnewswire.com prnewswire.com/news-releases/the-leukemia--lymphoma-society-lls-data-at-ash-provides-glimpse-into-the-future-of-blood-cancer-treatment-302310609.html

The Leukemia & Lymphoma Society (LLS) Data at ASH ... The findings from LLS's convened master clinical trials show great progress and are helping shape the treatment landscape for acute leukemias.

5. lls.org lls.org/sites/default/files/2021-08/PS80%20FactsBook_2020_2021_FINAL.pdf

FACTS 2020-2021 * Data specified for “blood cancer” include leukemia, lymphoma and myeloma ... LLS Blood Cancer Conferences are free educational events where blood ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05745285

Leukemia and Lymphoma Society (LLS) Services Impact ... 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 ...