Stem Cell Transplant for Hematological Malignancy

Summary

The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood.

The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.

Conditions

• Leukemia, Myeloid, Chronic
• AML
• Leukemia, Lymphocytic, Acute
• MDS
• Leukemia, Lymphocytic, Chronic
• JMML
• Hodgkin's Disease
• Non-hodgkin's Lymphoma
• Multiple Myeloma

Interventions

BIOLOGICAL

Stem Cell Transplant

Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)

DRUG

Cyclophosphamide

60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.

RADIATION

Total Body Irradiation

On Day -4, -3, -2, -1 total body irradiation is given twice daily.

DRUG

Busulfan

When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.

DRUG

Equine ATG (ATGAM)

UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines

BIOLOGICAL

CD4+/CD25+ cells

On days -2, patients will receive CD4+/CD25+ cells intravenously.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Daniel Weisdorf, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-10-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• United States

Study Locations