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New treatment option for Acute Myeloid Leukemia
Official title Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
ClinicalTrials.gov ID: NCT02508038
What this study is testing
What is Zoledronate?
Zoledronate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Zoledronic Acid, Zometa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 21
You may be able to join if
- 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...
- Relapsed or primary therapy-refractory AML with bone marrow blast \< 20%
You likely can't join if
- Pregnant or breast-feeding
- HIV infection
- Heart failure or uncontrolled cardiac rhythm disturbance
- Uncontrolled, Serious Active Infection
- Prior organ allograft
- Significant serious intercurrent illness unrelated to cancer or its treatment not covered by other exclusion criteria expected to significantly...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 Solid Tumor
- 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) for Donors:
- 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...
- 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)
What rules you out
- Pregnant or breast-feeding
- HIV infection
- Heart failure or uncontrolled cardiac rhythm disturbance
- Uncontrolled, Serious Active Infection
- Prior organ allograft
- Significant serious intercurrent illness unrelated to cancer or its treatment not covered by other exclusion criteria expected to significantly increase the risk of HSCT
- 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...
- 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) Exclusion Criteria for Donors:
- Lactating females
- Pregnant females
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 months to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.