Is NCT02508038 recruiting in Madison, WI?

Yes, NCT02508038 is currently recruiting participants at its Madison, WI location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Madison?

To join this clinical trial in Madison, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Madison clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Madison, WI

About This Acute Myeloid Leukemia Study in Madison

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.

Sponsor: University of Wisconsin, Madison

Who Can Participate

Inclusion Criteria

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 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) Inclusion Criteria 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 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 Criteria

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 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) Exclusion Criteria for Donors:

Lactating females

Pregnant females

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Madison?

Yes, this clinical trial (NCT02508038) has an active research site in Madison, WI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Madison, WI

If you're searching for acute myeloid leukemia treatment options in Madison, WI, this clinical trial (NCT02508038) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Madison research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Madison, WI

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