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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


Phase 2
55 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival-incidence of survival without relapse

Outcome Description:

Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.

Outcome Time Frame:

By 1 year after transplant

Safety Issue:

No

Principal Investigator

Brenda Sandmaier

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

1654.00

NCT ID:

NCT00045435

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Secondary Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Chronic

Name

Location

OHSU Cancer InstitutePortland, Oregon  97239
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109