Haploidentical Transplant and Zoledronate for Pediatric Cancers
This study is testing a new approach for children and young adults (ages 7 months to 21 years) with high-risk blood cancers (like leukemia or lymphoma) or solid tumors. It combines a special type of stem cell transplant, called a haploidentical transplant, with a drug called Zoledronate. The transplant uses stem cells from a partially matched family member, which are specially prepared to reduce certain cells (TCRαβ+ and CD19+) that can cause complications. Zoledronate is given after the transplant. Researchers want to see how safe this combination is, specifically looking at how often patients experience acute graft-versus-host disease (GVHD) within 100 days and graft failure by day 28. You may be eligible if you have a suitable haploidentical donor and no fully matched sibling or unrelated donor.
- Study design
- This is an interventional study with a planned enrollment of 22 participants. It is not specified if it is randomized or blinded.
- What's involved
- Patients will receive conditioning chemotherapy before the transplant. After the transplant, Zoledronate will be given intravenously five times, every 28 days. Additional medications to prevent GVHD may also be given.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track the incidence of acute graft-versus-host disease (GVHD) for 100 days after transplantation and graft failure at day 28.
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NCT02508038
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Recruiting
PHASE1Ages 7–21InterventionalTreatmentUniversity of Wisconsin, MadisonInvestigator-initiated
~22 participants
Updated 2025-10-16 on ClinicalTrials.gov
What's tested:TCRαβ+/CD19+ depleted Haploidentical HSCTZoledronate
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of acute graft versus host disease (GVHD)
Measured over Within 100 days post-transplantation
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesWisconsin1
Study leadership
- Christian Capitini, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Availability of an eligible haploidentical donor
Hematologic malignancy or solid tumor
Patients with more than one malignancy (hematologic or solid tumor) are eligible
Patients with hematologic malignancy must have no HLA identical sibling or suitable unrelated donor OR time needed to find an acceptable unrelated donor match would likely result in disease progression such that the patient may become ineligible for any type of potentially curative transplant
Relapsed or primary therapy-refractory AML with bone marrow blast \< 20%
High-risk refractory or relapsed ALL in patients for whom transplantation is deemed indicated (relapse occurring \< 30 months from diagnosis, patients relapsing after previous allogeneic transplant, relapse after 2nd remission, primary induction failure or hypodiploidy)
Relapsed Hodgkin lymphoma unable to achieve 2nd remission or Very Good Partial Response (VGPR) and therefore ineligible to receive autologous hematopoietic stem cell transplant (auto-HSCT)
Hodgkin lymphoma relapsing after auto-HSCT
Primary refractory or relapsed non-Hodgkin lymphoma unable to achieve 2nd remission or VGPR and therefore ineligible to receive auto-HSCT
Non-Hodgkin lymphoma relapsing after auto-HSCT
Myelodysplastic Syndrome/Myeloproliferative Syndrome
Patients with solid tumor must have failed or have been ineligible to receive auto-HSCT or if auto-HSCT would not offer \> 20% chance of cure
Neuroblastoma
high risk with relapsed or refractory disease
Soft tissue sarcomas (Rhabdomyosarcoma, Ewing sarcoma, Primitive Neuroectodermal Tumor or other high-risk extracranial solid tumors)
Relapsed or primary refractory metastatic
1st complete remission, but very high-risk features (i.e., \< 20% survival with conventional therapy)
Osteosarcoma
Failure to achieve Complete Response (CR) following initial therapy
Relapsed with pulmonary or bone metastases and did not achieve a CR with surgery and/or chemotherapy
Karnofsky (patients \> 16 years) or Lansky (patients 16 years or older) performance score of ≥ 60
Life expectancy of ≥ 3 months
Patient must have fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Study enrollment no earlier than 3 months after preceding HSCT
Glomerular Filtration Rate (GFR) ≥ 60 ml/min/1.73m2
Total bilirubin \< 3 mg/dL
ALT (alanine aminotransferase, SCPT) ≤ 5 x Upper LImit of Normal (ULN) for age
Ejection fraction of \> 40% by Multigated Acquisition Scan (MUGA) or echocardiogram
No evidence of dyspnea at rest
No supplemental oxygen requirement
If measured, carbon monoxide diffusion capacity (DLCO) \>50%
No severe peripheral neuropathy, signs of leukoencephalopathy or active Central Nervous System (CNS) infection
Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsant therapy
If of reproductive potential, negative pregnancy test and willing to use effective birth control method
Informed consent from patient or legal guardian (if patient is minor)
Donor must be 18 years of age minimum, 65 years of age maximum
Donor must be in good general health as determined by evaluating medical provider
Must meet donor criteria for human cells, tissues, and cellular and tissue-based products per Code of Federal Regulations 21 CFR 1271, subpart C. Specifically:
Donor screening in accordance with 1271.75 indicates that the donor:
Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and
Is free from communicable disease risks associated with xenotransplantation; and
The results of donor testing for relevant communicable disease agents in accordance with 1271.80 and 1271.85 are negative or nonreactive, except as provided in 1271.80(d)(1).
Haploidentical by HLA-typing
Preference will be given to donors who demonstrate KIR incompatibility with recipient HLA class I ligands defined as the donor expressing a KIR gene for which the corresponding HLA class I ligand is not expressed by the recipient.
Negative testing for relevant communicable diseases:
Hepatitis B surface antigen (HBsAg)
Hepatitis B core antibody (Anti-HBc)
Hepatitis C antibody (Anti-HCV)
HIV 1 \& 2 antibody (Anti-HIV-1, 2 plus O)
HTLV I/II antibody (Anti-HTLV I/II)
RPR (Syphilis TP)
CMV (Capture CMV)
MPX for: HepB (HBV-PCR), HepC (HCV-PCR), HIV (HIV-PCR)
NAT for West Nile Virus (WNV-PCR)
T. Cruzi - EIA (Chagas)
Exclusion
Pregnant or breast-feeding
HIV infection
Heart failure or uncontrolled cardiac rhythm disturbance
Uncontrolled, Serious Active Infection
Prior organ allograft
Any mental or physical condition, in the opinion of the PI (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the study
Enrollment in any other clinical study from screening up to Day 100 (unless PI judges such enrollment would not interfere with endpoints of this study)
Lactating females
Pregnant females
What this trial measures
- Incidence of acute graft versus host disease (GVHD)Within 100 days post-transplantation
- Incidence of graft failureAt day 28