Fludarabine + TBI for Stem Cell Transplant Recipients

Not yet recruiting at 2 trial locations

Overseen By Oncology Clinical Research Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hackensack Meridian Health

Disqualifiers: Active infections, Prior allogeneic transplant, 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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining fludarabine, a chemotherapy drug, with intermediate-dose total body irradiation (TBI), followed by post-transplant cyclophosphamide, can improve one-year survival rates for patients undergoing stem cell transplants. It targets individuals with specific blood cancers, such as leukemia and lymphoma, who qualify for an allogeneic stem cell transplant (using donor stem cells). This trial suits those with these blood cancers who can undergo the transplant process. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using fludarabine with a moderate amount of total body irradiation (TBI) is generally safe and effective. Past studies demonstrated that this combination works well and is safe. For instance, patients receiving this treatment for certain transplants experienced manageable side effects and achieved long-lasting survival rates.

One study found that this treatment was well-tolerated even when stem cell donors were not perfect matches, indicating that side effects are not too severe compared to the potential benefits. Overall, while all medical treatments carry some risks, evidence suggests that fludarabine and moderate-dose TBI are safe for use in stem cell transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Fludarabine with intermediate-dose Total Body Irradiation (TBI) for stem cell transplant recipients because this combination offers a unique approach to conditioning before a transplant. Unlike traditional high-dose chemotherapy, which can be harsh on the body, Fludarabine is less toxic and, when used with TBI, can effectively prepare the body for a transplant without overwhelming side effects. Additionally, this method includes post-transplant Cyclophosphamide to help reduce the risk of graft-versus-host disease, a common complication after transplants. This innovative approach aims to improve transplant outcomes and patient recovery, making it a promising option for those undergoing stem cell transplants.

What evidence suggests that this trial's treatments could be effective for improving 1-year survival in stem cell transplant recipients?

Research has shown that using fludarabine with a moderate dose of total body irradiation (TBI) can be effective for individuals undergoing stem cell transplants. In this trial, participants will receive fludarabine and intermediate-dose TBI, followed by post-transplant cyclophosphamide. Studies have found that most patients tolerate this treatment without severe side effects. This approach is considered safe and effective, helping patients live longer after their transplants. In previous studies, 45% of patients with visible disease experienced complete remission, meaning their disease was no longer detectable. This suggests that the treatment could be highly beneficial for recipients. ^{1 2 3 6 7}

Who Is on the Research Team?

Michele Donato, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for individuals who are receiving an allogeneic stem cell transplant to treat blood cancers. Participants must meet specific health criteria, which aren't detailed here.

Inclusion Criteria

Patients able to comply with follow-up visits and treatment plans

Patients able to give informed consent

Participants of reproductive potential must use effective contraception post-transplant

Exclusion Criteria

Hematopoietic cell transplantation comorbidity index above 3

Patients with prior allogeneic transplant

Patients unable to comply with follow-up visits and treatment plans

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive fludarabine and intermediate-dose total body irradiation (TBI) as a conditioning regimen before stem cell transplant

6 days

Daily visits for treatment administration

Transplant and Immediate Post-transplant

Hematopoietic stem cells are infused, followed by post-transplant cyclophosphamide and other medications for GVHD prophylaxis

35 days

Frequent monitoring and medication administration

Follow-up

Participants are monitored for safety, effectiveness, and GVHD symptoms post-transplant

1 year

Assessments every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Fludarabine
• Intermediate-dose Total Body Irradiation (TBI)
• Post-transplant Cyclophosphamide (PTCy)

Trial Overview The study tests if a combination of fludarabine and intermediate-dose TBI followed by PTCy can improve 1-year survival rates in stem cell transplant recipients. It's a phase 2 study conducted across multiple centers without comparison groups.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 5 Interventions

Fludarabine and Intermediate-dose Total Body Irradiation (800 cGy) Followed by Post-transplant Cyclophosphamide

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Citations

1. astctjournal.org astctjournal.org/article/S2666-6367(24)00585-2/fulltext

Total Body Irradiation and Fludarabine with Post- ... Total body irradiation- and fludarabine-based myeloablative conditioning regimen was well tolerated in mismatched related and unrelated donor ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666636724005852

Total Body Irradiation and Fludarabine with Post- ... Total body irradiation- and fludarabine-based myeloablative conditioning regimen was well tolerated in mismatched related and unrelated donor HCT recipients.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061767/

Intermediate-dose TBI/fludarabine conditioning for ... AlloHCT with intermediate-dose TBI/fludarabine conditioning is associated with a favorable toxicity/efficacy profile and can provide durable survival.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07214688

Fludarabine and Intermediate-dose TBI Followed by PTCy ... The Flu-TBI 800 trial is a prospective, single-arm, multicenter, interventional phase 2 study to evaluate whether fludarabine plus intermediate-dose total ...

5. ashpublications.org ashpublications.org/blood/article/101/4/1620/105963/Low-dose-total-body-irradiation-TBI-and

Low-dose total body irradiation (TBI) and fludarabine followed ... The 100-day transplantation-related mortality was 11%. Complete remissions, including molecular remissions, were seen in 45% of patients with measurable disease ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0041134522007734

Outcomes of Busulfan, Fludarabine, and 400 cGy Total ... The FB-TBI showed trends toward improvement in progression-free survival (PFS) and overall survival (OS) over FB (5-year PFS rates 50% vs 34%, P = .06, and 5- ...

7. nature.com nature.com/articles/s41409-023-01965-x

Fludarabine/TBI 8 Gy vs fludarabine/treosulfan AML: study We conclude that both conditioning regimens are effective and safe, but FluTBI may better be reserved for younger patients below the age of 55 years.