Stem Cell Transplant for Blood Cancer

Age: < 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Julie-An M. Talano

Disqualifiers: No suitable donor, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stem cell transplant method for individuals with certain blood cancers, such as leukemia and lymphoma, to determine if it can improve survival without cancer recurrence for at least a year. The treatment uses special machines (CliniMACS) to prepare the stem cells, aiming to reduce complications typically associated with transplants. It suits those with blood cancers in remission or a controlled phase who lack a perfectly matched donor. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer care.

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.

What prior data suggests that the CliniMACS system and peripheral blood stem cell transplantation are safe?

Research has shown that peripheral blood stem cell transplantation (PBSC) is generally safe and usually has fewer serious side effects than bone marrow donation. This is encouraging because PBSC is often easier for patients to handle.

Studies have found that using a device called CliniMACS to remove certain white blood cells (alpha beta T-cells) makes the transplant process safer. This method helps prevent a common complication called graft versus host disease (GVHD), where the donor's cells attack the recipient's body.

In summary, evidence suggests that this treatment is generally well-tolerated and carries a lower risk of serious issues. This should reassure anyone considering joining a trial involving these treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the treatment involving CliniMACS and Peripheral Blood Stem Cell Transplantation for blood cancer because it introduces a novel approach to stem cell transplants. Unlike traditional methods, this treatment involves depleting Alpha Beta T cells from the graft, which could potentially reduce the risk of complications like graft-versus-host disease. This selective T cell depletion is achieved using the CliniMACS device, which precisely targets unwanted cells, allowing for a more tailored and potentially safer transplant. By refining the transplant process, this treatment could offer a more effective and less risky option for blood cancer patients.

What evidence suggests that this trial's treatments could be effective for blood cancer?

Research has shown that using the CliniMACS system to remove certain T cells in blood stem cell transplants may help treat blood cancers. In this trial, all participants will receive this treatment approach. Studies have found that this method can lower the risk of graft-versus-host disease (GVHD), a common issue in stem cell transplants. Early results indicate that patients receiving this treatment experience better outcomes, including higher chances of successful engraftment, where the transplanted stem cells start to grow and produce healthy blood cells. Evidence also suggests that patients have higher one-year leukemia-free survival rates with this approach. These findings indicate that the CliniMACS system could be a promising option for patients with blood cancers. ^{2 3 6 7 8}

Who Is on the Research Team?

Julie-An Talano

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for patients under 23 years old with various blood cancers, including lymphoma and leukemia, who are in remission or have less than 10% bone marrow blasts. It's open to all genders and races but excludes those without a suitable donor or who don't meet specific disease, organ function, or infection criteria.

Inclusion Criteria

I am younger than 23 years old.

My condition is acute myeloid leukemia.

My condition is in a specific phase of chronic illness.

Exclusion Criteria

There is no available person who can donate what is needed for the study.

My condition does not match the specific disease, organ, or infection criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants undergo conditioning regimen prior to stem cell transplantation

1-2 weeks

Transplantation

Participants receive peripheral stem cell transplantation with alpha beta T cell and CD19+ B cell depletion

1 day

Engraftment

Monitoring for engraftment defined as ANC >500 for the first of 3 consecutive days

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and incidence of GVHD and TRM

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CliniMACS
• Peripheral Blood Stem Cell Transplantation

Trial Overview The study tests the CliniMACS device's ability to deplete Alpha Beta T cells plus CD19+ B cells from stem cell transplants in patients with blood cancers using alternative donors. The goal is to see how well it works by looking at engraftment success, avoidance of GVHD (graft-versus-host disease), and one-year survival without leukemia.

How Is the Trial Designed?

Group I: Single Experimental Arm Experimental Treatment 1 Intervention

Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device

Who Is Running the Clinical Trial?

Julie-An M. Talano

Lead Sponsor

Trials

1

Recruited

60+

Miltenyi Biotec, Inc.

Industry Sponsor

Trials

11

Recruited

280+

Published Research Related to This Trial

In a study of 215 patients receiving autologous peripheral blood progenitor cell (PBPC) infusions, 56.9% experienced infusion-related adverse reactions, highlighting the need for careful monitoring during treatment.

Factors such as female gender, multiple myeloma diagnosis, and the number of granulocytes infused per kg body weight were significant predictors of these adverse reactions, indicating that patient characteristics and graft composition play crucial roles in infusion safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity related to autologous peripheral blood haematopoietic progenitor cell infusion is associated with number of granulocytes in graft, gender and diagnosis of multiple myeloma. Bojanic, I., Cepulic, BG., Mazic, S., et al.[2011]

Peripheral blood stem cell transplantation can lead to severe complications, such as graft versus host disease (GVH) and subsequent organ failure, particularly in immunocompromised patients.

Adenoviral infections pose a significant risk for these patients, potentially leading to fatal outcomes, highlighting the need for improved diagnostics and early treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multiple organ failure and disseminated adenoviral infection]. Bretonnière, C., Touzeau, C., Guillaume, T., et al.[2010]

Allogeneic peripheral blood stem cell transplantation (allo-PBSCT) showed a significantly lower relapse rate (5.7%) compared to autologous PBSCT (auto-PBSCT) which had a relapse rate of 38.9%, indicating better long-term efficacy in treating malignant hematologic diseases.

The study found that allo-PBSCT resulted in a higher disease-free survival rate (69.5%) compared to auto-PBSCT (57.9%), suggesting that allo-PBSCT may be a more effective treatment option for patients with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peripheral blood stem cell transplantation for 53 patients with malignant hematologic diseases]. Xie, XS., Wan, DM., Sun, H., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02323867

Allogeneic Stem Cell Transplant With Alpha/Beta T AND B ... This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05517

T Cell Receptor Alpha/Beta Depletion Peripheral Blood ... This phase II trial tests how well T cell receptor Alpha/Beta depletion (A/B TCD) peripheral blood stem cell transplantation works to prevent graft versus host ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4211312/

Alpha/Beta T-Cell Depleted Grafts as an Immunological ... In this pilot study, five patients transplanted with HLA-matched related and unrelated donors were treated with αβ T-cell depleted stem cell boosts.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02600208

Study Details | NCT02600208 | Peripheral Blood Stem Cell ... The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04337515

CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem ... The optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03615144

Study Details | NCT03615144 | TCR Alpha Beta T-cell and ... The purpose of this study is to find out if removing a specific type of white blood cell (called alpha beta T-cell) that help make up the transplant donor's ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6944939/

Depletion of αβ+ T and B Cells Using the CliniMACS Prodigy We report the results of the first ten TCRαβ+ and B cell depletion procedures for clinical use performed at our centre.

8. withpower.com withpower.com/trial/phase-2-and-3-neoplasms-9-2015-04726

Stem Cell Transplant for Blood Cancer · Info for Participants Peripheral blood stem cell transplantation (PBSC) is generally considered safe, with a lower risk of serious adverse events compared to bone marrow donation. In ...