Status:
TERMINATED
Donor Stem Cell Transplant in Treating Patients With Myeloid Cancer or Other Disease
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
Center for International Blood and Marrow Transplant Research
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving total-body irradiation and chemotherapy, such as fludarabine and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop t...
Detailed Description
OBJECTIVES: Primary * Determine the incidence of disease-free survival at 1 year in patients with acute or chronic myeloid leukemias undergoing T-cell-depleted hematopoietic stem cell transplantatio...
Eligibility Criteria
Inclusion
- Primary acute myeloid leukemia (AML)
- First complete remission (CR) with high risk features as defined by: failure to achieve remission by day 21 after induction chemotherapy, or the presence of chromosomal abnormalities involving any of the following: -5/de (5q), -7/del(7q), inversion 3q, abnormalities of 11q23, 20q, 21q, del(9q), translocation 6;9, translocation 9;22, abnormalities of 17p, or complex karyotype with \> or = 3 abnormalities. Complete remission is defined as \< 5% blasts in the marrow.
- Second CR or subsequent in remission
- Refractory or relapsed disease with absolute peripheral blood blasts \< 2000/mcL
- Secondary AML in remission or relapse
- Chronic myelogenous leukemia (CML) in accelerated or blast phase
- Accelerated phase is defined by any one of the following:
- Blasts 10% to 19% of peripheral blood white cells or bone marrow cells
- Peripheral blood basophils at least 20%
- Persistent thrombocytopenia (\<100 x 10\^9/L) unrelated to therapy, or persistent thrombocytosis (\>1000 x 10\^9/L) unresponsive to therapy
- Increasing spleen size and increasing white blood cell (WBC) count unresponsive to therapy
- Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase CML)
- Resistance to tyrosine kinase inhibitors (imatinib or other) defined as no complete cytogenetic response even if the above criteria are not met.
- Blast phase is defined by either of the following:
- Blasts 20% or more of peripheral blood white cells or bone marrow cells
- Extramedullary blast proliferation
- Large foci or clusters of blasts in bone marrow biopsy
- Primary myelodysplastic syndrome (MDS) with an IPSS score \>1
- Secondary MDS with any international prostate symptom score (IPSS)
- Age ≤60 years
- Co-Morbidity score 0-2
- At least 35 days following start of preceding leukemia induction therapy
Exclusion
- Patients for whom a suitable HLA genotypically identical sibling or fully matched HLA-A, -B, -C, and -DRB1 unrelated donor is available.
- Patients greater than 60 years of age.
- Hypersensitivity to thymoglobulin.
- Symptomatic uncontrolled coronary artery disease or congestive heart failure.
- Hepatic disease with transaminases or bilirubin \> 2 times upper limit of normal (ULN) except for isolated hyperbilirubinemia attributed to Gilbert's syndrome.
- Severe hypoxemia with room air - Partial Pressure of Oxygen in Arterial Blood - (PAO2) \< 70, supplemental oxygen-dependence, or carbon monoxide diffusing capacity (DLCO) \< 50% predicted.
- Impaired renal function with creatinine \> 2 times upper limit of normal (ULN) or creatinine clearance measured by 24-hour urine collection \< 50% normal for age, gender, and weight.
- Patients with central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy.
- Patients who are human immunodeficiency virus (HIV) seropositive.
- Patients who are pregnant or breast-feeding.
- Patients with active infections that are untreated, or failing to respond to appropriate therapy.
- Karnofsky performance status \< 50%.
- Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplant.
- Inability to provide informed consent.
- Co-morbidity score \>2
- Less than 35 days from start of previous leukemia induction therapy
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00392782
Start Date
July 1 2005
End Date
May 1 2011
Last Update
December 28 2017
Active Locations (9)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
3
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
4
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455