T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

Summary

The primary aim of this protocol is to evaluate if the one-year survival is significantly improved in the group of patients who receive a T-cell replete haploidentical donor hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen. Study population will consist of patients (21 years or under) with hematologic malignancies that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be evaluated by the rate of transplant related mortality and the rates of moderate and severe graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and disease-free survival at one year, as well as the rates of hematopoietic recovery and donor engraftment and study comprehensively immune reconstitution following T-cell replete haploidentical transplantation.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelocytic Leukemia
• Chronic Myelocytic Leukemia
• Juvenile Myelomonocytic Leukemia
• Myelodysplastic Syndrome
• Hodgkin or Non-Hodgkin Lymphoma
• Sarcoma, Myeloid

Interventions

DRUG

clofarabine

Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent

DRUG

cytarabine

Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent

DRUG

busulfan

Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent

DRUG

Plerixafor

Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: Hematopoietic Stem Cell Mobilizer

DRUG

cyclophosphamide

Given on Day -5 and Day +4 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent; immunosuppressive agent.

DRUG

antithymocyte globulin (rabbit)

Given on Day -4, Day -3, Day -2, and Day -1 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.

BIOLOGICAL

stem cells

Patients undergo T cell replete Hematopoietic stem cell infusion on Day 0 and Day +1. Patients undergo natural killer (NK) cell transplantation on day +6 (Day 0 is first stem cell infusion).

DRUG

Tacrolimus

Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.

DRUG

mycophenolate mofetil

Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.

Sponsors & Collaborators

• Assisi Foundation

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Brandon M. Triplett, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations