Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission

2014-08-27 03:54:53 | BioPortfolio


RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops 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 tacrolimus and methotrexate after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by a donor stem cell transplant works in treating older patients with acute myeloid leukemia that is in the first complete remission.




- Determine whether allogeneic stem cell transplantation from a matched sibling or unrelated donor using a nonmyeloablative preparative regimen comprising fludarabine and busulfan results in a 2-year disease-free survival that is better than historical results using standard chemotherapy in older patients with acute myeloid leukemia in first morphologic complete remission.


- Determine the 2-year actuarial risks of transplant-related mortality, acute and chronic graft-versus-host disease, and relapse in patients treated with this regimen.

- Determine the recovery of T- and B-cell number and function and the time course of T, B, and myeloid progenitor chimerism in patients treated with this regimen.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral or IV tacrolimus twice daily starting on days -2, with tapering between days 90-120, and stopping by days 150-180. Patients also receive methotrexate IV on days 1, 3, 6,and 11 and rabbit antithymocyte globulin (Thymoglobulin) IV over 4-6 hours on days -4 through -2.

- Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo allogeneic PBSC transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 12 and continuing until blood counts recover. Patients with progressive disease will be removed from the study and may receive additional treatment at the discretion of the investigator.

Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment




filgrastim, graft-versus-tumor induction therapy, busulfan, fludarabine phosphate, methotrexate, tacrolimus, peripheral blood stem cell transplantation


UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:54:53-0400

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Medical and Biotech [MESH] Definitions

The induction of prolonged survival and growth of allografts of either tumors or normal tissues which would ordinarily be rejected. It may be induced passively by introducing graft-specific antibodies from previously immunized donors, which bind to the graft's surface antigens, masking them from recognition by T-cells; or actively by prior immunization of the recipient with graft antigens which evoke specific antibodies and form antigen-antibody complexes which bind to the antigen receptor sites of the T-cells and block their cytotoxic activity.

An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.

Immunological rejection of tumor tissue/cells following bone marrow transplantation.

Immunized T-lymphocytes which can directly destroy appropriate target cells. These cytotoxic lymphocytes may be generated in vitro in mixed lymphocyte cultures (MLC), in vivo during a graft-versus-host (GVH) reaction, or after immunization with an allograft, tumor cell or virally transformed or chemically modified target cell. The lytic phenomenon is sometimes referred to as cell-mediated lympholysis (CML). These CD8-positive cells are distinct from NATURAL KILLER CELLS and NATURAL KILLER T-CELLS. There are two effector phenotypes: TC1 and TC2.

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

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