Geriatric Assessment for Blood Disorders

Not currently recruiting at 8 trial locations

Overseen By Roni Tamari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Prior transplant, Cord blood donors, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a geriatric assessment (GA) can improve treatment outcomes for older patients with certain blood disorders, such as acute myeloid leukemia, who are about to undergo chemotherapy or a stem cell transplant. The assessment evaluates thinking skills, movement, mood, nutrition, and current medications to tailor treatment more effectively. It also seeks to determine if this approach enhances participants’ quality of life through regular questionnaires. Ideal candidates are those aged 60 or older with a confirmed blood disorder preparing for transplant treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study includes a review of your current medications as part of the geriatric assessment, it's possible that adjustments might be recommended.

What prior data suggests that this geriatric assessment is safe for older patients with blood disorders?

Research has shown that geriatric assessments (GA) are generally safe for older adults with blood disorders like acute myeloid leukemia. These assessments help identify risks and improve treatment customization, aiding in managing potential side effects from treatments like chemotherapy or stem cell transplants.

In past studies, geriatric assessments have not caused any serious side effects. Instead, they have helped doctors better understand patients' needs, allowing them to adjust treatment plans to reduce risks and improve patient comfort. For example, one study found that patients who underwent a geriatric assessment before their treatments experienced better outcomes and fewer complications.

Overall, evidence suggests that geriatric assessments are well-tolerated and serve as a useful tool in managing treatment for older adults with blood disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of geriatric assessment (GA) for blood disorders because it offers a personalized approach to treatment. Unlike standard options, which often apply a one-size-fits-all method, GA involves evaluating older patients' health comprehensively before a transplant. This assessment helps tailor the intensity of treatment to the individual's needs, potentially reducing risks and improving outcomes. Additionally, GA provides ongoing supportive care management, which can enhance recovery and quality of life for elderly patients. This innovative approach promises to make transplants safer and more effective for older adults with blood disorders.

What evidence suggests that a geriatric assessment is effective for improving treatment outcomes in older patients with myeloid malignancies?

Research has shown that using a geriatric assessment (GA) before a transplant can help identify issues in older patients with blood disorders. This trial will include GA pre-transplant, risk-adapted allocation of conditioning intensity based on GA, and GA-directed, longitudinal supportive care management. The assessment evaluates memory, physical ability, and mood to tailor treatments more effectively. Studies have found that patients with health problems before a transplant may experience worse outcomes, so early identification and management of these issues are crucial. Other research suggests that GA helps identify weaknesses that might lead to treatment side effects, enabling doctors to plan more effectively. Overall, using GA has been linked to better treatment results and improved quality of life for older patients facing these serious conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

Richard j Lin, MD, PhD

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 certain blood disorders like acute myeloid leukemia and related conditions, who have a suitable donor for stem cell transplant. They must meet the standard criteria for transplantation and have less than 10% of immature cells (blasts) in their bone marrow.

Inclusion Criteria

have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor

I have a confirmed diagnosis of a myeloid blood disorder.

have <10% blasts in bone marrow prior to transplant

Exclusion Criteria

This clinical trial does not involve cord blood donors.

My bone marrow has more than 10% cancer cells before transplant.

I have had a bone marrow or stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Geriatric Assessment

Participants undergo a geriatric assessment to evaluate cognitive function, physical function, mobility, mood, nutrition, and current medications to determine treatment approach

1-2 weeks

Treatment

Participants receive risk-adapted conditioning regimens (MA or RIC/NMA) based on geriatric assessment, including chemotherapy and possibly radiation therapy

6-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life through questionnaires after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric assessment (GA) pre-transplant

Trial Overview The study tests if a geriatric assessment before an allogeneic hematopoietic stem cell transplant can improve treatment outcomes and quality of life in older patients. This includes evaluating cognitive function, physical ability, mood, nutrition, and medications.

How Is the Trial Designed?

Group I: Geriatric participants with various blood disorders Experimental Treatment 3 Interventions

1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7271571/

Geriatric assessment in older patients with a hematologic ... The median age of the patients was 73 years (range, 58-86) and 71% had a good World Health Organization (WHO) performance status. The median prevalence of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04761770

NCT04761770 | Study of a Geriatric Assessment to Plan a ... This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10042624/

Geriatric Assessment Reveals Actionable Impairments in ... Outcomes are worse in patients who begin HCT with functional impairments. To detect such impairments, a geriatric assessment (GA) is recommended in adults age ≥ ...

4. astctjournal.org astctjournal.org/article/S2666-6367(25)01048-6/fulltext

US Geriatric Assessment for Older Adults HCT/CAR T Therapy Geriatric assessment (GA) may identify vulnerabilities and promote risk-stratification in older adults predisposed to toxicities after autologous (auto), ...

5. ashpublications.org ashpublications.org/bloodadvances/article/4/12/2810/461070/Geriatric-assessment-in-older-alloHCT-recipients

Geriatric Assessment in Older alloHCT Recipients: Outcomes Pretransplant data provided by the CIBMTR included demographic, disease-related, and transplant-related variables. The primary outcome measure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7322958/

Geriatric assessment in older alloHCT recipients: association ... Impact of geriatric vulnerabilities on allogeneic hematopoietic cell transplantation outcomes in older patients with hematologic malignancies.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406820304914

Recommendations and outcomes from a geriatric ... Patients pursuing autoHCT after MDC-directed optimization achieved excellent outcomes, including patients deferred but ultimately receiving autoHCT.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6690603/

Pre-transplant Comprehensive Geriatric Assessment in ... For the 15 patients who did not undergo transplant, the estimated one-year overall survival was 88% (95% CI, 0.41–0.98) from the date of CGA.