Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

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Brief Title

Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

Official Title

Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission

Brief Summary

      This phase II trial studies how well reduced intensity donor peripheral blood stem cell
      (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia
      (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and
      total-body irradiation (TBI) before a donor PBSC 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 cells and help destroy any remaining
      cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can
      also make an immune response against the body's normal cells. Giving cyclosporine and
      mycophenolate mofetil after the transplant may stop this from happening
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine if a one-year disease free survival of >= 35% can be achieved among patients
      >= 55 years old with de novo and secondary AML in first complete remission (CR1) who undergo
      nonmyeloablative hematopoietic stem cell transplant (HSCT) from human leukocyte antigen (HLA)
      identical related donors.

      II. To determine if a day +200 nonrelapse related mortality of < 15% can be achieved among
      patients >= 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative
      HSCT from HLA identical related donors.

      OUTLINE:

      CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to
      -2 and undergo TBI on day 0.

      TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0.

      IMMUNOSUPPRESSION: Patients receive cyclosporine (CSP) orally (PO) twice daily (BID) on days
      -3 to 56 with taper to day 77. Patients also receive mycophenolate mofetil (MMF) PO BID on
      days 0-27.

      After completion of study treatment, patients are followed up on days 28, 56, and 84; months
      6, 12, 18, and 24; and then yearly for 5 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease-free Survival-incidence of Survival Without Relapse

Secondary Outcome

 Overall Survival

Condition

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome

Intervention

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Study Arms / Comparison Groups

 Treatment (nonmyeloablative donor PBSC transplant)
Description:  CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0.
IMMUNOSUPPRESSION: Patients receive CSP PO BID on days -3 to 56 with taper to day 77. Patients also receive MMF PO BID on days 0-27.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

17

Start Date

April 2002

Completion Date

January 2009

Primary Completion Date

January 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with de novo AML (French-American-British [FAB] MO-M2, M4-M7) or secondary
             AML who achieve CR1 after induction chemotherapy and one or two cycles of
             consolidation chemotherapy

          -  Transplant conditioning must occur within 6 months of diagnosis

          -  Patient enrollment must be approved by the Fred Hutchinson Cancer Research Center
             (FHCRC) principal investigator (PI) or the PI's designee

          -  DONOR: Related donor who is genotypically or phenotypically identical

          -  DONOR: Age >= 12 years

          -  DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

          -  DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
             central venous catheter (femoral, subclavian)

        Exclusion Criteria:

          -  AML FAB M3

          -  AML involvement of the central nervous system (CNS) as defined by a positive cytospin
             of cerebral spinal fluid at the time of enrollment

          -  Presence of circulating leukemic blasts (in the peripheral blood) detected by standard
             pathology

          -  Human immunodeficiency virus (HIV) seropositivity

          -  Fungal infections with radiographic progression after receipt of amphotericin B or
             active triazole for greater than one month

          -  Diffusion capacity of carbon monoxide (DLCO) corrected < 40%

          -  Total lung capacity (TLC) < 40%

          -  Forced expiratory volume in one second (FEV1) < 40% or requiring supplementary oxygen

          -  The FHCRC principal investigator of the study must approve enrollment of all patients
             with pulmonary nodules

          -  Cardiac ejection fraction < 40%

          -  Patients with clinical or laboratory evidence of liver disease would be evaluated for
             the cause of liver disease, its clinical severity in terms of liver function, bridging
             fibrosis, and the degree of portal hypertension; patients will be excluded if they are
             found to have fulminant liver failure, cirrhosis of the liver with evidence of portal
             hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding
             esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic
             dysfunction evinced by prolongation of the prothrombin time, ascites related to portal
             hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral
             hepatitis with total serum bilirubin > 3mg/dL, or symptomatic biliary disease

          -  Karnofsky Performance Score < 70

          -  Fertile men or women unwilling to use contraceptive techniques during and for 12
             months following treatment

          -  Females who are pregnant or breastfeeding

          -  No intensive chemotherapy can be given within three weeks (or the interval in which a
             cycle of standard chemotherapy would be administered in a non-transplant setting)
             prior to initiating the nonmyeloablative transplant conditioning

          -  Patients with active non-hematologic malignancies (except non-melanoma skin cancers)

          -  Patients with a history of non-hematologic malignancies (except non-melanoma skin
             cancers) currently in a complete remission, who are less than 5 years from the time of
             complete remission, and have a > 20% risk of disease recurrence

          -  Patients with active bacterial or fungal infections unresponsive to medical therapy

          -  DONOR: Identical twin

          -  DONOR: Pregnancy

          -  DONOR: HIV seropositivity

          -  DONOR: Inability to achieve adequate venous access

          -  DONOR: Known allergy to G-CSF

          -  DONOR: Current serious systemic illness
      

Gender

All

Ages

55 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Brenda Sandmaier, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00045435

Organization ID

1654.00

Secondary IDs

NCI-2011-01307

Responsible Party

Principal Investigator

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Brenda Sandmaier, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Verification Date

January 2020