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Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

NCT01660607 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-08-19

Study results available
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Summary

This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.

Conditions

  • Myeloid Leukemia, Chronic
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndromes (MDS)
  • Lymphoma, Non-Hodgkin
  • Acute Lymphoblastic Leukemia (ALL)
  • Myeloproliferative Syndrome
  • Acute Myeloid Leukemia
  • Acute Leukemia
  • Chronic Myelogenous Leukemia

Interventions

BIOLOGICAL

CD34+ Hematopoietic Progenitor Cells (HSPC)

Purified CD34+ hematopoietic progenitor cells used in transplantation.

BIOLOGICAL

Regulatory T-Cells (Treg)

Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease.

BIOLOGICAL

Conventional T-Cells (Tcon)

Conventional CD3+ T cells used for immune reconstitution and graft enhancement.

PROCEDURE

Myeloablative Conditioning Regimen

Chemotherapy or total body irradiation used before hematopoietic cell transplantation.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Everett Meyer · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
13 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-09
Primary Completion
2023-12-20
Completion
2023-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660607 on ClinicalTrials.gov