Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
54

Summary

Conditions
  • Acute Leukemia
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • Lymphoma Non-Hodgkin
  • Myelodysplastic Syndromes (MDS)
  • Myeloid Leukemia, Chronic
  • Myeloproliferative Syndrome
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 13 years and 60 years
Gender
Both males and females

Description

Primary Objectives: To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) ...

Primary Objectives: To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic progenitor cells ("CD34+ HSPC")], without immune suppression. To determine the maximum tolerated dose of infused regulatory and conventional T cells in the matched donor setting To determine 1 year event free survival (EFS) post HCT Secondary Objectives: To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors. To measure the incidence and severity of acute and chronic graft vs host disease (GvHD) To measure incidence of serious infections

Tracking Information

NCT #
NCT01660607
Collaborators
National Institutes of Health (NIH)
Investigators
Principal Investigator: Everett Meyer Stanford University