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

Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02323867
• Other study ID #: 13-010495
• Secondary ID: BT13BT?51
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Children's Hospital of Philadelphia
• Contact: Patricia Hankins, BSN, RN, CCRC
• Phone: 215-590-5168
• Email: hankinsp[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Device:
• Alpha Beta T cell depletion

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days		1 year
Secondary	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.	1 year