Stem Cell Transplantation for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to make stem cell transplants safer for leukemia patients by preventing Graft-Versus-Host Disease (GVHD), a common side effect where donor cells attack the patient's healthy tissues. The study examines whether removing certain immune cells, specifically through Selective Depletion of CD45RA+ T Cells, from donor stem cells can reduce GVHD while still combating leukemia. It targets patients with types of leukemia who are already scheduled for a stem cell transplant. Those with a history of leukemia or related conditions planning to undergo a transplant might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial information does not specify if 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 treatment is likely to be safe?
Research has shown that a new method in stem cell transplants, which involves removing certain T cells, may reduce the risk of acute graft-versus-host disease (GVHD). GVHD occurs when donor cells attack the patient's healthy tissues after a transplant, a common concern. One study found that the chance of developing moderate to severe GVHD within 28 days of the transplant was 0% at one dose level, 20% at another, and 10% at a third.
This method aims to retain the beneficial effects of donor T cells while minimizing their harmful effects. Although these results are promising, this approach is still under study, and individual experiences may vary. It is crucial to discuss potential risks and benefits with a healthcare team before deciding to join a trial.12345Why are researchers excited about this study treatment for leukemia?
Researchers are excited about the stem cell transplantation technique for leukemia because it uniquely uses selective depletion of CD45RA+ T cells to potentially reduce the risk of graft-versus-host disease (GVHD), a common complication in traditional transplants. Unlike standard treatments that might not specifically target these cells, this approach aims to enhance the safety and effectiveness of the transplant by minimizing immune reactions. Additionally, the use of G-CSF-mobilized, CD34-enriched peripheral blood stem cells is designed to improve the chances of successful engraftment, which can lead to better outcomes for patients. This innovative method holds the promise of making stem cell transplants safer and more effective for leukemia patients.
What evidence suggests that the selective depletion of CD45RA+ T cells might be an effective treatment for leukemia?
Research has shown that a special technique in stem cell transplants, which participants in this trial will receive, can help reduce the risk of Graft-Versus-Host Disease (GVHD), a common complication. In a study with 35 patients who had high-risk acute leukemia, this method lowered the severity of GVHD and aided better immune system recovery. The technique removes certain T cells, known as naïve T cells, believed to cause GVHD, while preserving the T cells that fight leukemia and infections. Other studies have found that this method helps maintain the body's ability to remember and fight infections after the transplant. These findings suggest that this approach might make stem cell transplants safer and more effective for treating leukemia.12367
Who Is on the Research Team?
Marie Bleakley
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for patients aged 0-60 with acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia who are suitable for stem cell transplantation. They must have a matched donor and acceptable organ function. Exclusions include uncontrolled infections, severe heart/lung/kidney disease, previous certain transplants, pregnancy/breastfeeding without contraception use, other significant medical conditions or participation in conflicting trials.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Patients undergo chemotherapy and total-body radiotherapy to prepare for transplantation
Transplant
Patients receive allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells
GVHD Prophylaxis
Patients receive medications to prevent graft-versus-host disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Selective Depletion of CD45RA+ T Cells
Trial Overview
The trial tests whether selectively removing naïve T cells from donor stem cells before transplant can prevent Graft-Versus-Host-Disease (GVHD) while preserving the benefits of fighting infections and killing residual leukemia cells. It involves high/medium intensity chemo/radiotherapy followed by infusion of modified donor blood stem cells.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Research Center
Lead Sponsor
Fred Hutchinson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT02220985?cond=%22Blastic%20Plasmacytoid%20Dendritic%20Cell%20Neoplasm%22&intr=%22anti-bacterial%20agents%22&viewType=Table&rank=4Selective Depletion of CD45RA+ T Cells From Allogeneic ...
This phase II trial is for patients with acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia who have been ...
Selective depletion of naïve T cells by targeting CD45RA - PMC
In their study, 35 patients with high-risk acute leukemia received these CD45RA+-depleted grafts from MSDs after myeloablative conditioning. No ...
Selective Depletion of CD45RA+T Cells From Allogeneic ...
PURPOSE: This phase II trial will determine whether the removal of the naive T cells from donor cells can decrease the rate and severity of graft-vs-host ...
Selective T-cell depletion targeting CD45RA reduces viremia ...
We hypothesized that specific depletion of CD45RA+ naïve T cells, rather than broad depletion of CD3+ T cells, can preserve memory-immunity in the allografts.
Feasibility and Efficacy of CD45RA+ Depleted Donor ...
Feasibility and efficacy of CD45RA+ depleted donor lymphocytes infusion after haploidentical transplantation with post-transplantation cyclophosphamide.
Selective TCRαβ+ and CD45RA+ T-cell depletion of ...
CD45RA depletion resulted in a median 4.8 (4.3–5.2) log reduction, with CD3+/CD45RO+ cell recovery at 41% (34%–47%) and CD34 recovery at 58% (51 ...
Depletion of CD45RA + T cells: Advantages and ...
Stem cell recovery after one-step CD45RA-depletion was at median 52.0% (range: 49.7–67.2%), which was comparable to previously published recovery data received ...
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