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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

No Placebo-Only Group

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 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

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met