A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

Summary

This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.

Conditions

• Ewing Sarcoma
• Gastrointestinal Tumor
• Germ Cell Tumor
• Hepatic Tumor
• Lymphoma
• Wilms Tumor
• Rhabdoid Tumor
• Clear Cell Carcinoma
• Renal Cell Carcinoma
• Melanoma
• Neuroblastoma
• Rhabdomyosarcoma
• Non-rhabdomyosarcoma

Interventions

DRUG

melphalan

Patients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.)

DRUG

sirolimus

Patients receive sirolimus beginning on day -1 with taper beginning on day 90. (Day 0 = stem cell transplantation.) Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy.

DRUG

Busulfan

Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.)

DRUG

alemtuzumab

Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation).

DRUG

fludarabine

Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.)

BIOLOGICAL

stem cells

Patients undergo CD3 depleted haploidentical hematopoietic stem cell transplant (HSCT) on day 0. Patients also undergo CD45RA depleted HSCT infusion on day 1. (Day 0 = stem cell transplantation.)

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.

Sponsors & Collaborators

• CURE Childhood Cancer, Inc.

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-20

Primary Completion

2020-02-10

Completion

2020-02-10

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations