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Claudia Maria Hattinger, Maria Pia Patrizio, Federica Magagnoli...
https://pubmed.ncbi.nlm.nih.gov/31401903Actively Recruiting
Phase 1
Age: 7Months - 21Years
All Genders
ID02508038
TCR-alpha/beta+ and CD19+ Depleted Haploidentical Stem Cell Transplant with Zoledronate for Pediatric Relapsed or Refractory Blood Cancers and High-Risk Solid Tumors
Led by University of Wisconsin, Madison · Updated on 2025-10-16
22
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a specialized stem cell transplant combined with the drug Zoledronate for children and young adults with relapsed or refractory blood cancers or high-risk solid tumors. This phase I trial focuses on using a haploidentical donor peripheral blood stem cell graft that has been depleted of certain immune cells (TCR alpha/beta+ and CD19+ cells) to reduce complications after transplant. Patients with high-risk leukemia receive a strong conditioning regimen including anti-thymocyte globulin, fludarabine, thiotepa, and total body irradiation, while others receive a reduced-intensity conditioning with similar drugs but different dosing. On day 0, patients undergo transplantation with the treated stem cell graft. If the graft has fewer than a set number of stem cells, a second graft may be given. To prevent graft-versus-host disease (GVHD), patients with higher immune cell counts receive specific medications like mycophenolate mofetil and tacrolimus. Zoledronate is given intravenously in five doses spaced 28 days apart, starting 28 days after transplant. During the study, participants are closely monitored for signs of acute GVHD within the first 100 days and for graft failure by day 28. Immune system recovery is followed for up to one year. The study uses detailed lab tests, imaging, and clinical assessments to track outcomes and safety. The total participation period includes the transplant, post-transplant drug dosing, and follow-up evaluations over months to assess transplant success and immune function.
CONDITIONS
Brief Title
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Who Can Participate
Age: 7Months - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
- Availability of an eligible haploidentical donor
- Diagnosis of hematologic malignancy or solid tumor
- Patients with multiple malignancies (hematologic or solid) are eligible
- Hematologic malignancy patients must lack HLA identical sibling or suitable unrelated donor, or have urgency to transplant
- Relapsed or refractory acute myeloid leukemia with bone marrow blast less than 20%
- High-risk relapsed or refractory acute lymphoblastic leukemia needing transplant
- Relapsed Hodgkin lymphoma not eligible for autologous transplant
- Relapsed or refractory non-Hodgkin lymphoma not eligible for autologous transplant
- Myelodysplastic or myeloproliferative syndrome
- Solid tumor patients must have failed or be ineligible for autologous transplant or have less than 20% chance of cure with it
- High-risk neuroblastoma with relapsed or refractory disease
- Relapsed or refractory metastatic soft tissue sarcomas
- Osteosarcoma patients with failure to achieve or lost complete response
- Karnofsky or Lansky performance score of 60 or higher
- Life expectancy of at least 3 months
- Fully recovered from prior chemotherapy, immunotherapy, or radiotherapy toxic effects
- At least 3 months since previous stem cell transplant
- Glomerular filtration rate at least 60 ml/min/1.73m2
- Total bilirubin less than 3 mg/dL
- Alanine aminotransferase less than or equal to 5 times upper limit of normal
- Ejection fraction greater than 40%
- No dyspnea at rest
- No supplemental oxygen requirement
- Carbon monoxide diffusion capacity greater than 50% if measured
- No severe peripheral neuropathy, leukoencephalopathy, or active CNS infection
- Seizures must be well controlled if present
- Negative pregnancy test if of reproductive potential and willing to use birth control
- Informed consent from patient or guardian
You will not qualify if you...
- Pregnant or breastfeeding
- HIV infection
- Heart failure or uncontrolled heart rhythm
- Uncontrolled serious active infection
- Prior organ transplant
- Serious illness unrelated to cancer expected to increase transplant risk
- Mental or physical condition interfering with study participation
- Enrollment in another clinical study from screening to day 100 unless approved
- Donor exclusion: lactating or pregnant females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Conditioning and Transplant
Duration - Approximately 2 weeks
Participants receive conditioning chemotherapy and/or radiation based on their disease risk, followed by a haploidentical stem cell transplant with TCR-alpha/beta+ and CD19+ depleted graft.
Daily visits during conditioning and transplant period
Zoledronate Treatment
Duration - Approximately 5 months
Participants receive five doses of Zoledronate intravenously, administered every 28 days starting 28 days after transplant.
5 visits (in-person) at 28 day intervals
Follow-up
Duration - Up to 1 year
Participants are monitored for graft-versus-host disease, graft failure, immune system recovery, and overall health after transplantation and Zoledronate treatment.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
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Research Team
J
Jenny Weiland
C
Celeste Matsushima
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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