Actively Recruiting
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Led by University of Wisconsin, Madison · Updated on 2025-10-16
22
Participants Needed
1
Research Sites
615 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial studies the safety of transplantation with a haploidentical donor peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction with the immunomodulating drug, Zoledronate, given in the post-transplant period to treat pediatric patients with relapsed or refractory hematologic malignancies or high risk solid tumors.
CONDITIONS
Official Title
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Availability of an eligible haploidentical donor
- Diagnosis of hematologic malignancy or solid tumor, including multiple malignancies
- For hematologic malignancy, no HLA identical sibling or suitable unrelated donor OR donor search time likely to cause disease progression
- Relapsed or primary therapy-refractory AML with less than 20% bone marrow blasts
- High-risk refractory or relapsed ALL meeting specified relapse criteria
- Relapsed Hodgkin lymphoma not achieving second remission or very good partial response
- Hodgkin lymphoma relapsing after autologous stem cell transplant
- Primary refractory or relapsed non-Hodgkin lymphoma not achieving second remission or very good partial response
- Non-Hodgkin lymphoma relapsing after autologous stem cell transplant
- Myelodysplastic or myeloproliferative syndromes
- Solid tumor patients failed or ineligible for autologous transplant or with less than 20% chance of cure
- Neuroblastoma with high-risk relapsed or refractory disease
- Soft tissue sarcomas with relapsed, refractory metastatic, or very high-risk features
- Osteosarcoma failing to achieve complete response or relapsed with metastases
- Karnofsky or Lansky performance score of 60 or higher
- Life expectancy of at least 3 months
- Fully recovered from toxic effects of previous treatments
- Enrollment at least 3 months after any prior stem cell transplant
- Glomerular filtration rate of 60 ml/min/1.73m2 or higher
- Total bilirubin less than 3 mg/dL
- Alanine aminotransferase no more than 5 times the upper limit of normal for age
- Ejection fraction greater than 40%
- No dyspnea at rest or oxygen requirement
- Carbon monoxide diffusion capacity greater than 50% if measured
- No severe peripheral neuropathy, leukoencephalopathy, or active CNS infection
- Well-controlled seizures if present
- Negative pregnancy test and use of birth control if of reproductive potential
- Informed consent from patient or guardian
- Donor age 18 to 65 years in good health and meeting federal donor screening criteria
- Donor haploidentical by HLA typing with preference for KIR incompatibility
- Donor negative for relevant communicable diseases
You will not qualify if you...
- Pregnant or breastfeeding
- HIV infection
- Heart failure or uncontrolled serious heart rhythm problems
- Uncontrolled serious active infection
- Previous organ transplant
- Serious illness unrelated to cancer increasing transplant risk
- Mental or physical conditions interfering with study adherence
- Enrollment in another clinical study from screening to day 100 unless allowed by investigator
- Donors who are pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
J
Jenny Weiland
CONTACT
C
Celeste Matsushima
CONTACT
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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