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Cell Therapy

Stem Cell Transplant for Blood Cancers (AB-CliniMACs Trial)

Q: What deleterious effects may come from Alpha Beta T cell depletion?

Alpha Beta T cell depletion has been shown to some degree of safety, so it was assigned a score of 2. The lack of data demonstrating efficacy precludes assigning the medication any higher rating at this stage in the trial process.

Q: Are there any vacancies remaining for individuals to participate in this experiment?

Indeed, clinicaltrials.gov has evidence that this medical trial is actively recruiting patients, having been posted for the public on October 1st 2014 and last modified on October 28th 2022. Enrollment criteria includes 140 participants from at least one location.

Q: What is the scale of participation in this experiment?

Affirmative, the information on clinicaltrials.gov confirms that this research is currently recruiting volunteers. It was initially published on October 1st 2014 and recently revised on October 28th 2022; 140 individuals must be enrolled from a solitary site.

Phase 2

Recruiting

Led By Nancy J Bunin, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Leukemias/lymphomas meeting specific disease status criteria (e.g., remission, <10% bone marrow blasts)

Negative pregnancy test for females of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

AB-CliniMACs Trial Summary

This trial is testing a new stem cell transplantation method for people with blood cancers. The new method uses a machine to remove certain cells from the donor stem cells, and it also removes a different type of cell from the patient before transplant. The trial will measure how well the transplant works and how long the patient survives without the cancer coming back.

Who is the study for?

This trial is for patients with various blood cancers like leukemia and lymphoma who are in remission or have minimal disease presence. They must have acceptable organ function, no active untreated infections, and a negative pregnancy test if applicable. Those who've had previous allogeneic transplants or lack a suitable donor can't participate.Check my eligibility

What is being tested?

The study tests α/β T cell-depleted peripheral Stem Cell Transplantation using alternative donors to treat blood cancers. It aims to see how well patients accept the transplant without developing graft versus host disease (GVHD) and their survival rate without leukemia after one year.See study design

What are the potential side effects?

Potential side effects may include complications from stem cell transplantation such as infection risks due to immune system suppression, reactions related to graft versus host disease, and issues arising from organ dysfunction.

AB-CliniMACs Trial Eligibility Criteria

Inclusion Criteria

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

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My leukemia/lymphoma is in remission or has less than 10% bone marrow blasts.

Select...

I am not pregnant.

AB-CliniMACs Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days

Secondary outcome measures

Severe acute and chronic graft versus host disease (GVHD)

AB-CliniMACs Trial Design

3Treatment groups

Experimental Treatment

Group I: Alpha Beta Total Body Irradiation - total body irradiation (TBI) firstExperimental Treatment1 Intervention

Alpha Beta Total Body Irradiation - TBI first Day Treatment 11 Anti-thymocyte globulin (ATG) 10 ATG 9 ATG 8 TBI 7 TBI 6 TBI 5 Thiotepa 4 Thiotepa 3 Cyclophosphamide 2 Cyclophosphamide 1 Rest 0 Transplant with alpha beta T cell depleted stem cells

Group II: Alpha Beta Total Body Irradiation - TBI lastExperimental Treatment1 Intervention

Alpha Beta Total Body Irradiation - TBI last Day Treatment 9 ATG 8 ATG 7 Thiotepa + ATG 6 Thiotepa 5 Cyclophosphamide 4 Cyclophosphamide 3 TBI 2 TBI 1 TBI 0 Transplant with alpha beta T cell depleted stem cells

Group III: Alpha Beta Non-irradiation regimenExperimental Treatment1 Intervention

Alpha Beta Non-irradiation regimen Day Treatment 9 Busulfan + ATG 8 Busulfan + ATG 7 Busulfan +ATG 6 Busulfan 5 Thiotepa 4 Thiotepa 3 Cyclophosphamide 2 Cyclophosphamide 1 0 Transplant with alpha beta T cell depleted stem cells

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,867 Total Patients Enrolled

15 Trials studying Leukemia

1,340 Patients Enrolled for Leukemia

Nancy J Bunin, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

3 Previous Clinical Trials

213 Total Patients Enrolled

1 Trials studying Leukemia

100 Patients Enrolled for Leukemia

Media Library

Allogeneic Stem Cell Transplant (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02323867 — Phase 2

Frequently Asked Questions

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

What deleterious effects may come from Alpha Beta T cell depletion?

"Alpha Beta T cell depletion has been shown to some degree of safety, so it was assigned a score of 2. The lack of data demonstrating efficacy precludes assigning the medication any higher rating at this stage in the trial process."

Answered by AI

Are there any vacancies remaining for individuals to participate in this experiment?

"Indeed, clinicaltrials.gov has evidence that this medical trial is actively recruiting patients, having been posted for the public on October 1st 2014 and last modified on October 28th 2022. Enrollment criteria includes 140 participants from at least one location."

Answered by AI

What is the scale of participation in this experiment?

"Affirmative, the information on clinicaltrials.gov confirms that this research is currently recruiting volunteers. It was initially published on October 1st 2014 and recently revised on October 28th 2022; 140 individuals must be enrolled from a solitary site."

Answered by AI

Recent research and studies

Blood AdvancesJournal

Leahy, Allison Barz, Yimei Li, Julie-An Talano, Caitlin W. Elgarten, Alix E. Seif, Yongping Wang, Bryon Johnson, et al.. 2022. “Unrelated Donor Α/β T Cell– and B Cell–depleted HSCT for the Treatment of Pediatric Acute Leukemia”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2021005492.

Blood AdvancesJournal

clinicaltrials.govStudy

Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Nancy Bunin 2014. "Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02323867.

All > Leukemia > Lymphoma