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

NCT ID: NCT02323867

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Lymphoma Myelodysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

intervention with device: Alpha Beta T cell depletion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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 Type EXPERIMENTAL

No interventions assigned to this group

Alpha Beta Total Body Irradiation - TBI last

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 Type EXPERIMENTAL

No interventions assigned to this group

Alpha Beta Non-irradiation regimen

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

Group Type EXPERIMENTAL

Alpha Beta T cell depletion

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alpha Beta T cell depletion

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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
2. Acceptable organ status clearance
3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
4. Signed informed consent.
5. Negative pregnancy test for females of childbearing potential.

Exclusion Criteria

1. Patients who do not meet disease, organ or infectious criteria.
2. No suitable donor
3. 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.
Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Timothy Olson

Medical Director, Hematopoietic Stem Cell Transplantation (HSCT) Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Timothy Olson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34872106 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BT13BTθ51

Identifier Type: OTHER

Identifier Source: secondary_id

13-010495

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.