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Immunotherapy

Stem Cell Transplant + Zometa for Pediatric Blood Cancers

Q: Is the FDA sanctioned to perform TCRαβ+/CD19+ depleted Haploidentical HSCT?

Due to the early stage of research, TCRαβ+/CD19+ depleted Haploidentical HSCT is rated a 1 for safety as it has limited evidence in its efficacy and security.

Q: Is there an age limitation for participants of this medical experiment?

The given eligibility criteria stipulate that participants must fall between 7 months and 21 years of age.

Q: Is there still an opportunity for individuals to join this research endeavor?

Affirmative, clinicaltrials.gov appears to depict that this research is still seeking participants. The investigation was initially advertised on February 12th 2016 and recently modified on March 1st 2022; the endeavour needs 22 volunteers from a single medical centre.

Q: To which ailments is TCRαβ+/CD19+ depleted Haploidentical HSCT typically employed?

TCRαβ+/CD19+ depleted Haploidentical HSCT is a procedure that can help address tumors, solid tissues, bone mineral density issues, and chemotherapy-based maladies.

Q: How many participants are currently involved in this medical experiment?

That is accurate. According to clinicaltrials.gov, this medical trial began recruiting on February 12th 2016 and was last edited on March 1st 2022. 22 patients are required for the single-site study.

Q: Are there any other experiments involving TCRαβ+/CD19+ depleted Haploidentical Hematopoietic Stem Cell Transplantation?

Presently, 36 clinical trials are exploring TCRαβ+/CD19+ depleted Haploidentical HSCT. Of those in operation, 8 have advanced to Phase 3. While the vast majority of these studies take place at Douliu, Yunlin County, there are 694 different centres conducting research into this type of treatment.

Q: Who meets the criteria for participation in this clinical research?

This clinical trial is seeking 22 individuals between the ages of 7 months and 21 years who possess <a href="https://www.withpower.com/clinical-trials/rhabdomyosarcoma">rhabdomyosarcoma</a>. To be eligible, participants must also meet additional requirements such as not having an HLA identical sibling or a suitable unrelated donor, relapsed Hodgkin <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> unable to achieve a 2nd remission or Very Good Partial Response (VGPR) and therefore ineligible for auto-HSCT, primary refractory or relapsed non-Hodgkin lymphoma unable to achieve 2nd remission or VGPR and ineligible for auto-HSCT, availability of an eligible haploidentical donor hematologic mal

Phase 1

Recruiting

Led By Mario Otto, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a new way to transplant stem cells from a donor who is only a half-match to the patient, using a drug to remove TCRαβ+ cells and CD19+ cells.

Who is the study for?

This trial is for pediatric patients with high-risk or relapsed blood cancers and solid tumors who have a suitable haploidentical donor. It's not open to those pregnant, breastfeeding, with uncontrolled infections, prior organ transplants, or conditions that could affect study participation.Check my eligibility

What is being tested?

The trial tests a transplant using stem cells from a half-matched donor that are filtered to remove certain immune cells (TCRαβ+/CD19+), combined with Zoledronate post-transplant. This Phase I study aims to assess the safety of this approach.See study design

What are the potential side effects?

Potential side effects may include complications from the stem cell transplant like infection risk due to immune suppression and reactions related to Zoledronate such as fever, bone pain, and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have blood cancer and either can't find a matching donor or can't wait for one without my disease getting worse.

Select...

My AML is not responding to treatment and my bone marrow has less than 20% cancer cells.

Select...

I have been diagnosed with a blood disorder affecting my bone marrow.

Select...

My Hodgkin lymphoma has returned and I can't have a stem cell transplant.

Select...

My non-Hodgkin lymphoma did not respond well to initial treatments and is not eligible for a specific stem cell transplant.

Select...

My solid tumor cannot be treated with a stem cell transplant.

Select...

My neuroblastoma is high risk and has come back or didn't respond to treatment.

Select...

My leukemia has returned or didn't respond to treatment, and I need a transplant.

Select...

My Hodgkin lymphoma has returned after a stem cell transplant.

Select...

My non-Hodgkin lymphoma has returned after a stem cell transplant.

Select...

My cancer is a high-risk type and has come back or didn't respond to initial treatment.

Select...

I have a blood cancer or a solid tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of acute graft versus host disease (GVHD)

Incidence of graft failure

Secondary outcome measures

Immune reconstitution

Biotin

Trial Design

1Treatment groups

Experimental Treatment

Group I: TCRαβ+/CD19+ depleted Haploidentical HSCT+ ZoledronateExperimental Treatment2 Interventions

Patients with high-risk leukemia (who are at least one year of age and who have not received TBI as conditioning for a previous HSCT) will receive myeloablative conditioning with ATG, Fludarabine, Thiotepa, and TBI. All other subjects will undergo a reduced-intensity conditioning regimen consisting of ATG, Fludarabine, Thiotepa, and Melphalan prior to transplant with a KIR/KIR ligand mismatched haploidentical donor peripheral blood stem cell graft depleted of TCR-αβ+ and CD19+ cells. Patients will receive 5 doses of zoledronate (at 28 day intervals) starting 28 days after stem cell transplant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zoledronate

2016

Completed Phase 4

~480

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,183 Previous Clinical Trials

3,167,565 Total Patients Enrolled

Mario Otto, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Christian Capitini, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

TCRαβ+/CD19+ depleted Haploidentical HSCT (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02508038 — Phase 1

Acute Myeloid Leukemia Research Study Groups: TCRαβ+/CD19+ depleted Haploidentical HSCT+ Zoledronate

Acute Myeloid Leukemia Clinical Trial 2023: TCRαβ+/CD19+ depleted Haploidentical HSCT Highlights & Side Effects. Trial Name: NCT02508038 — Phase 1

TCRαβ+/CD19+ depleted Haploidentical HSCT (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02508038 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the FDA sanctioned to perform TCRαβ+/CD19+ depleted Haploidentical HSCT?

"Due to the early stage of research, TCRαβ+/CD19+ depleted Haploidentical HSCT is rated a 1 for safety as it has limited evidence in its efficacy and security."

Answered by AI

Is there an age limitation for participants of this medical experiment?

"The given eligibility criteria stipulate that participants must fall between 7 months and 21 years of age."

Answered by AI

Is there still an opportunity for individuals to join this research endeavor?

"Affirmative, clinicaltrials.gov appears to depict that this research is still seeking participants. The investigation was initially advertised on February 12th 2016 and recently modified on March 1st 2022; the endeavour needs 22 volunteers from a single medical centre."

Answered by AI

To which ailments is TCRαβ+/CD19+ depleted Haploidentical HSCT typically employed?

"TCRαβ+/CD19+ depleted Haploidentical HSCT is a procedure that can help address tumors, solid tissues, bone mineral density issues, and chemotherapy-based maladies."

Answered by AI

How many participants are currently involved in this medical experiment?

"That is accurate. According to clinicaltrials.gov, this medical trial began recruiting on February 12th 2016 and was last edited on March 1st 2022. 22 patients are required for the single-site study."

Answered by AI

Are there any other experiments involving TCRαβ+/CD19+ depleted Haploidentical Hematopoietic Stem Cell Transplantation?

"Presently, 36 clinical trials are exploring TCRαβ+/CD19+ depleted Haploidentical HSCT. Of those in operation, 8 have advanced to Phase 3. While the vast majority of these studies take place at Douliu, Yunlin County, there are 694 different centres conducting research into this type of treatment."

Answered by AI

Who meets the criteria for participation in this clinical research?

"This clinical trial is seeking 22 individuals between the ages of 7 months and 21 years who possess rhabdomyosarcoma. To be eligible, participants must also meet additional requirements such as not having an HLA identical sibling or a suitable unrelated donor, relapsed Hodgkin lymphoma unable to achieve a 2nd remission or Very Good Partial Response (VGPR) and therefore ineligible for auto-HSCT, primary refractory or relapsed non-Hodgkin lymphoma unable to achieve 2nd remission or VGPR and ineligible for auto-HSCT, availability of an eligible haploidentical donor hematologic mal"

Answered by AI

Recent research and studies

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

clinicaltrials.govStudy

Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors

2016. "Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02508038.

All > Osteosarcoma > Rhabdomyosarcoma