Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission

Summary

The reason for doing this study is to determine whether a new method of blood stem cell transplant (also known as bone marrow transplant) is able to treat acute lymphocytic leukemia. Blood stem cells are the "seed cells" necessary to make all blood cells. This new method of transplant uses a combination of low dose radiation and chemotherapy that may be less toxic and cause less harm than a conventional transplant. This lower dose transplant is called a "nonmyeloablative transplant". Researchers want to see if using less radiation and less chemotherapy combined with new immune suppressing drugs after the transplant will help a stem cell transplant to work. Researchers hope that this treatment will cure acute lymphocytic leukemia with fewer side effects. Researchers are hoping to see a mixture of recipient and donor blood cells after transplant. This mixture of donor and recipient blood cells is called "mixed chimerism". Researchers hope that donor cells will attack and eliminate the leukemia. This is called the "graft-versus-leukemia" effect. In addition, after the transplant, white blood cells from the donor may be given to enhance or "boost" the graft-versus-leukemia effect, and hopefully remove all remaining cancer cells. This study is being done because at the present time blood stem cell transplantation (or bone marrow transplantation) is the only known curative therapy for acute lymphocytic leukemia. Because of age or underlying health status acute lymphocytic leukemia patients have a higher likelihood of experiencing severe harm from a conventional blood stem cell transplant. Researchers are doing this study to see if this new nonmyeloablative method of low dose radiation and low dose chemotherapy given before transplant and immune suppressive drugs after transplant will help make the transplant safer and also cure acute lymphocytic leukemia

Conditions

• Adult Acute Lymphoblastic Leukemia in Remission
• Childhood Acute Lymphoblastic Leukemia in Remission
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Lymphoblastic Leukemia

Interventions

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo nonmyeloablative allogeneic PBSCT

BIOLOGICAL

donor lymphocytes

Given IV

DRUG

cyclosporine

Given PO

RADIATION

total-body irradiation

Undergo TBI

DRUG

fludarabine phosphate

Given IV

DRUG

mycophenolate mofetil

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

PROCEDURE

peripheral blood stem cell transplantation

Undergo nonmyeloablative allogeneic PBSCT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  lead OTHER

Principal Investigators

• George Georges · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-09-30

Primary Completion

2006-08-31

Completion

2012-11-30

Countries

• United States

Study Locations