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Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies (AB-CliniMACs)

Primary Purpose

Leukemia, Lymphoma, Myelodysplasia

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Alpha Beta T cell depletion

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Transplant, Alternative Donor

Eligibility Criteria

undefined - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Leukemias/lymphomas
- Acute myeloid leukemia, primary or secondary Disease status: remission or <10% bone marrow blasts
- Myelodysplasia
- Acute lymphoblastic leukemia Disease status: in hematologic remission
- Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
- Mixed lineage or biphenotypic acute leukemia
- Lymphoblastic lymphoma Disease status: remission
- Burkitt's lymphoma/leukemia: Disease status- in remission
Acceptable organ status clearance
No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
Signed informed consent.
Negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

Patients who do not meet disease, organ or infectious criteria.
No suitable donor
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.

Sites / Locations

The Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Alpha Beta Total Body Irradiation - total body irradiation (TBI) first

Alpha Beta Total Body Irradiation - TBI last

Alpha Beta Non-irradiation regimen

Arm Description

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

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

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

Outcomes

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)

Estimation of the incidence and extent of acute and chronic GVHD. The overall incidence of acute GVHD, the incidence of Grade 4 acute GVHD and the incidence of chronic GVHD.

Full Information

NCT ID

NCT02323867

First Posted

October 22, 2014

Last Updated

October 3, 2023

Sponsor

Children's Hospital of Philadelphia

1. Study Identification

Unique Protocol Identification Number

NCT02323867

Brief Title

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

Acronym

AB-CliniMACs

Official Title

UNRELATED AND PARTIALLY MATCHED RELATED DONOR PERIPHERAL STEM CELL TRANSPLANTATION WITH Alpha/Beta T CELL AND B CELL DEPLETION FOR PATIENTS WITH HEMATOLOGIC MALIGNANCIES

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma, Myelodysplasia

Keywords

Transplant, Alternative Donor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

intervention with device: Alpha Beta T cell depletion

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alpha Beta Total Body Irradiation - total body irradiation (TBI) first

Arm Type

Experimental

Arm Description

Arm Title

Alpha Beta Total Body Irradiation - TBI last

Arm Type

Experimental

Arm Description

Arm Title

Alpha Beta Non-irradiation regimen

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Alpha Beta T cell depletion

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Severe acute and chronic graft versus host disease (GVHD)

Description

Estimation of the incidence and extent of acute and chronic GVHD. The overall incidence of acute GVHD, the incidence of Grade 4 acute GVHD and the incidence of chronic GVHD.

Time Frame

1 year

10. Eligibility

Sex

All

Maximum Age & Unit of Time

23 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Leukemias/lymphomas Acute myeloid leukemia, primary or secondary Disease status: remission or <10% bone marrow blasts Myelodysplasia Acute lymphoblastic leukemia Disease status: in hematologic remission Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase. Mixed lineage or biphenotypic acute leukemia Lymphoblastic lymphoma Disease status: remission Burkitt's lymphoma/leukemia: Disease status- in remission Acceptable organ status clearance No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic Signed informed consent. Negative pregnancy test for females of childbearing potential. Exclusion Criteria: Patients who do not meet disease, organ or infectious criteria. No suitable donor 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Margaret Tartaglione, RN

Phone

215-590-4029

tartaglione@chop.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Patricia Hankins, RN

Phone

215-590-4029

hankinsp@chop.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy J Bunin, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Margaret Tartaglione, RN

Phone

215-590-4029

tartaglione@chop.edu

First Name & Middle Initial & Last Name & Degree

Patricia Hankins, RN

Phone

215-590-5168

hankinsp@chop.edu

First Name & Middle Initial & Last Name & Degree

Nancy J Bunin, MD

First Name & Middle Initial & Last Name & Degree

Stephan A Grupp, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34872106

Citation

Leahy AB, Li Y, Talano JA, Elgarten CW, Seif AE, Wang Y, Johnson B, Monos DS, Kadauke S, Olson TS, Freedman J, Wray L, Grupp SA, Bunin N. Unrelated donor alpha/beta T cell- and B cell-depleted HSCT for the treatment of pediatric acute leukemia. Blood Adv. 2022 Feb 22;6(4):1175-1185. doi: 10.1182/bloodadvances.2021005492.

Results Reference

derived

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

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