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Cell Therapy

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

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
Must not have
Received previous allogeneic transplant. Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele, or a related HLA match other than a sibling.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.
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.
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.

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.
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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a transplant from a donor who is not my sibling.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Severe acute and chronic graft versus host disease (GVHD)

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

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
721 Previous Clinical Trials
8,604,187 Total Patients Enrolled
16 Trials studying Leukemia
1,420 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
Timothy Olson, MD, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
6 Previous Clinical Trials
305 Total Patients Enrolled
2 Trials studying Leukemia
150 Patients Enrolled for Leukemia

Media Library

Allogeneic Stem Cell Transplant (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02323867 — Phase 2
~13 spots leftby Oct 2025