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Status:

COMPLETED

Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Acute Myeloid Leukemia

Adult Acute Megakaryoblastic Leukemia

Eligibility:

All Genders

18-74 years

Phase:

PHASE2

Brief Summary

This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients ...

Detailed Description

PRIMARY OBJECTIVE: I. To determine if this treatment can improve 2-year progression-free survival (PFS) in patients with high risk myelodysplastic syndrome (MDS) and in patients with acute myeloid le...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Meets one of the following sets of criteria:
  • Myelodysplastic syndromes (MDS):
  • Disease with high-risk features (found either at diagnosis or before initiation of cytotoxic therapy), defined as one of the following:
  • International prognostic scoring system (IPSS) risk \>= intermediate-2
  • Refractory anemia with excess blasts by French-American-British (FAB) classification
  • High-risk cytogenetics (either complex or -7)
  • Less than 10% bone marrow blasts as determined by bone marrow biopsy within the past 4 weeks (reduction in marrow blast percentage may be achieved with chemotherapy or other therapy)
  • Less than 75 years old
  • Acute myeloid leukemia (AML):
  • No FAB M3
  • No acute leukemia following blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease
  • Patients with preceding MDS or treatment-related AML are eligible
  • Prior central nervous system (CNS) involvement is allowed provided the disease is in remission at transplantation
  • Morphologic complete remission (leukemia-free state) is defined as meeting all of the following criteria:
  • Bone marrow blasts \< 5% (as determined by bone marrow within the past 4 weeks), but without requirement for normal peripheral blood counts
  • No extramedullary leukemia
  • No blasts in peripheral blood
  • Achieved complete remission (CR) after no more than 2 courses of induction chemotherapy
  • Patients treated with azacitidine or decitabine who achieve a leukemia-free state are eligible (may have required up to 4 courses of therapy to reach this status)
  • Age 60 to 74 years
  • Donors must meet the following criteria:
  • One of the following:
  • HLA-identical sibling (6/6) by serologic typing for class (A, B) and low-resolution molecular typing for class II (DRB1)
  • Matched unrelated donor (8/8) by high-resolution molecular typing at HLA-A, -B, -C, and DRB1
  • No syngeneic donors
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Calculated creatinine clearance ≥ 40 mL/min
  • Bilirubin \< 2 mg/dL OR bilirubin 2-3 mg/dL provided direct bilirubin is normal
  • Aspartate aminotransferase (AST) \< 3 times upper limit of normal
  • Diffusing capacity of the lung for carbon monoxide (DLCO) \> 40% with no symptomatic pulmonary disease
  • Left ventricle ejection fraction (LVEF) \>= 30% by echocardiogram (ECHO) or multigated acquisition (MUGA)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled diabetes mellitus or active serious infections
  • No known hypersensitivity to E. coli-derived products, azacitidine, or mannitol
  • No human immunodeficiency virus (HIV) infection or active hepatitis B or C
  • Prior azacitidine or decitabine allowed
  • No patients who progressed from MDS to AML during treatment with azacitidine or decitabine
  • At least 4 weeks since prior deoxyribonucleic acid (DNA)-hypomethylating chemotherapy, radiotherapy, and/or surgery
  • No more than 2 courses of consolidation therapy before transplantation (for patients with AML)
  • Any consolidation regimen that does not require transplantation can be used
  • No more than 6 months from documentation of morphologic CR to transplantation

Exclusion

    Key Trial Info

    Start Date :

    July 15 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2020

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT01168219

    Start Date

    July 15 2010

    End Date

    February 1 2020

    Last Update

    August 4 2022

    Active Locations (17)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (17 locations)

    1

    Beebe Medical Center

    Lewes, Delaware, United States, 19958

    2

    Christiana Care Health System-Christiana Hospital

    Newark, Delaware, United States, 19718

    3

    AdventHealth Orlando

    Orlando, Florida, United States, 32803

    4

    University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, United States, 52242