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Conditioning for Hematopoietic Stem Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies


Phase 2
N/A
60 Years
Open (Enrolling)
Both
Accelerated Phase Chronic Myelogenous Leukemia, 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(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Hematopoietic/Lymphoid Cancer, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Relapsing Chronic Myelogenous Leukemia

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Trial Information

Conditioning for Hematopoietic Stem Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies


PRIMARY OBJECTIVE:

I. Determine the incidence and severity of acute GvHD.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of IV busulfan including interdose variability and
evaluation of a limited sampling strategy.

II. Determine thymoglobulin pharmacokinetics. III. Determine the incidence of donor
engraftment. IV. Determine system toxicities >= Grade 3 per CTCAE v.3. V. Determine the
incidence and severity of chronic GvHD. VI. Determine the incidence of non-relapse mortality
at Day +100 and at 1 yr. VII. Determine the incidence of relapse. VIII. Determine
relapse-free survival. IX. Determine the incidence of EBV activation.

OUTLINE:

Patients receive fludarabine phosphate IV over 30 minutes on days -9 to -6, busulfan IV over
3 hours on days -5 to -2, and anti-thymocyte globulin IV over 6 hours on days -3 and -2 and
over 4 hours on day -1. Patients undergo donor peripheral blood stem cell transplant on day
0. Patients then receive tacrolimus IV continuously or orally every 12 hours beginning on
day -1 and taper to day 180 and methotrexate IV on days 1, 3, 6, and 11.

After completion of study treatment, patients are followed at 1 year.


Inclusion Criteria:



- Myelodysplastic syndromes (MDS) ( all risk groups)

- Chronic myelogenous leukemia in chronic phase, accelerated phase and treated blast
phase (CP2)

- Acute myeloid leukemia (AML) in remission or early relapse (< 10% marrow blasts)

- Other myeloproliferative disorders

- Related or unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 defined by high
resolution DNA typing or mismatched for a single HLA-A, B, C, DRB1 or DQB1 allele

- Age 12-75 years (donor)

Exclusion Criteria:

- Life expectancy severely limited by diseases other than malignancy

- Hepatic disease, with AST > 2 times normal

- Cardiac insufficiency requiring treatment or symptomatic coronary artery disease

- Severe hypoxemia , pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild
hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted

- Impaired renal function (creatinine > 2 times normal or estimated creatinine
clearance < 60 ml/min)

- HIV-positive patients due to risk of reactivation or acceleration of HIV replication

- Female patients who are pregnant or breast feeding due to risks to fetus from
conditioning regimen and potential risks to nursing infants

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence and severity of acute GvHD

Outcome Description:

Determined by LTFU.

Outcome Time Frame:

Day 100 post-transplant

Safety Issue:

No

Principal Investigator

Paul O'Donnell

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

1913.00

NCT ID:

NCT01056614

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Accelerated Phase Chronic Myelogenous Leukemia
  • 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(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Blastic Phase Chronic Myelogenous Leukemia
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Myelodysplastic Syndromes
  • Chronic Phase Chronic Myelogenous Leukemia
  • de Novo Myelodysplastic Syndromes
  • Hematopoietic/Lymphoid Cancer
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Relapsing Chronic Myelogenous Leukemia
  • Congenital Abnormalities
  • Blast Crisis
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109