Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes

Summary

This randomized phase II trial studies how well donor umbilical cord blood transplant with or without ex-vivo expanded cord blood progenitor cells works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy stem cells and ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded cord blood progenitor cells is more effective than giving a donor umbilical cord blood transplant alone.

Conditions

• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia in Remission
• Chronic Myelogenous Leukemia
• Myelodysplastic Syndrome

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given IV or PO

BIOLOGICAL

Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion

Given IV

DRUG

Fludarabine Phosphate

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

DRUG

Thiotepa

Given IV

RADIATION

Total-Body Irradiation

Undergo high dose or middle intensity TBI

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

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

  collaborator NIH

• Nohla Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Filippo Milano · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-11

Primary Completion

2018-09-18

Completion

2020-05-29

FDA Drug

Yes

Countries

• United States

Study Locations