Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

Summary

This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.

Conditions

• Adult Acute Lymphoblastic Leukemia in Remission
• Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
• Blastic Phase
• Childhood Acute Lymphoblastic Leukemia in Remission
• Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase of Disease
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Disease

Interventions

DRUG

Cyclosporine

Given IV or PO

DRUG

Dasatinib

Given PO

DRUG

Fludarabine Phosphate

Given IV

DRUG

Imatinib Mesylate

Given PO

DRUG

Mycophenolate Mofetil

Given PO

DRUG

Nilotinib

Given PO

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo nonmyeloablative allogeneic PBSC transplantation

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSC transplantation

BIOLOGICAL

Therapeutic Allogeneic Lymphocytes

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• George Georges · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-07-13

Primary Completion

2014-07-31

Completion

2018-05-31

Countries

• United States

Study Locations