Skip to content
Triangle logo TriangleGet started
← Study library

NCT00392782 · REGISTRY CONDITION SEARCH

Donor Stem Cell Transplant in Treating Patients With Myeloid Cancer or Other Disease

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-12-28

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 the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with myeloid cancer or other disease.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Incidence of Disease-free Survival

→

outcome · POSTED

Incidence of Disease Relapse

→

outcome · POSTED

Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)

→

outcome · POSTED

Incidence of Chronic Graft-versus-host Disease (GVHD)

→

outcome · POSTED

Incidence of Graft Failure

→

outcome · POSTED

Transplant-related Mortality

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
healthy Volunteers
false
maximum Age
60 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: fludarabine phosphate
    3. Drug: thiotepa
    4. Procedure: peripheral blood stem cell transplantation
    5. Radiation: total-body irradiation
    label
    Natural Killer Cell Kir Epitope
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Natural Killer Cell Kir Epitope
    description
    Rabbit thymoglobulin will be given intravenously at a dose of 2.5 mg/kg on days -5,-4, -3, and -2. The first dose of thymoglobulin will be given over six (6) hours and subsequent doses over four (4) or more hours as tolerated or, per institutional anti-thymocyte globulin (ATG) administration guidelines.
    name
    anti-thymocyte globulin
    other Names
    1. ATG
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Natural Killer Cell Kir Epitope
    description
    Fludarabine 40 mg/m\^2/day intravenously (IV) over 30-60 minutes on days -7,-6,-5,-4,-3 (total dose 200 mg/m\^2).
    name
    fludarabine phosphate
    other Names
    1. Fludara
    type
    DRUG
  3. arm Group Labels
    1. Natural Killer Cell Kir Epitope
    description
    Thiotepa 5 mg/kg/day intravenously (IV) over 4 hours on days -8, -7 (total dose 10 mg/kg).
    name
    thiotepa
    type
    DRUG
  4. arm Group Labels
    1. Natural Killer Cell Kir Epitope
    description
    Peripheral Blood Stem Cell (PBSC) Infusion. All patients will receive granulocyte colony-stimulating factor (G-CSF)-mobilized PBSC on day 0 (or day+1 when available) following CD34 cell selection for ex vivo T cell removal. PBSC is infused via a central venous catheter using blood infusion tubing.
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBSC
    type
    PROCEDURE
  5. arm Group Labels
    1. Natural Killer Cell Kir Epitope
    description
    The total-body irradiation (TBI) will be given in 2 fractions of 400 cGy each administered on day -10 and -9 via anterior and posterior fields for a total dose of 800 cGy.
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
24
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients alive and without disease at 1 year after transplant.
    measure
    Incidence of Disease-free Survival
    time Frame
    1 Year
secondary Outcomes
  1. description
    Number of patients with disease at 1 year.
    measure
    Incidence of Disease Relapse
    time Frame
    1 Year
  2. description
    Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening.
    measure
    Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)
    time Frame
    Day 100
  3. description
    Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD.
    measure
    Incidence of Chronic Graft-versus-host Disease (GVHD)
    time Frame
    1 Year
  4. description
    Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.
    measure
    Incidence of Graft Failure
    time Frame
    Day 100
  5. description
    Number of patients with treatment related death at 1 year post transplant.
    measure
    Transplant-related Mortality
    time Frame
    1 Year
  6. description
    Number of patients who were deceased at 1 year post transplant.
    measure
    Overall Survival
    time Frame
    1 Year
Full study description
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 the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with myeloid cancer or other disease.
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 transplantation from HLA-C mismatched, unrelated donors. Secondary * Determine the incidence of disease relapse at 1 year in patients treated with this regimen. * Determine the incidence and severity of acute graft-vs-host disease (GVHD) at 100 days and chronic GVHD at 1 year in these patients. * Determine the incidence of graft failure at day 100. * Determine the transplant-related mortality of these patients at 1 year. * Determine the overall survival of these patients at 1 year. OUTLINE: This is a prospective, multicenter study. Patients are stratified according to killer-cell immunoglobulin-like receptors (KIR) epitope mismatch (yes \[experimental\] vs no \[control\]). * Myeloablative preparative regimen: Patients undergo total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. * Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0. After completion of study treatment, patients are followed periodically for at least 1 year.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-c41451a07abd671fb56b
      requested nct id
      NCT00392782
      primary nct id
      NCT00392782
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      payload sha256
      e4a90cb4513df57496a6fbbc69028b582a8d0cf92a0d93dbf7c9957d8450ed25
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-c41451a07abd671fb56b
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00392782
      occurrences
      1. context exact
        NCT00392782
        end
        11
        exact text
        NCT00392782
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Myelodysplastic Neoplasms
      query disease state id
      ds-myelodysplastic-neoplasms-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-myelodysplastic-neoplasms-000.json
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      source json pointer
      /studies/32/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e613b7c3cbdd2903d53dfa38ea99d60f10b39c57dc18f5c47ab431fe29141d07
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-e977f326fe25aec05f40
      requested nct id
      NCT00392782
      primary nct id
      NCT00392782
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      payload sha256
      1b10a3b27cf6537554ffb09a0ad47574a0ebe87adfa46c50066052e4a895747c
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e977f326fe25aec05f40
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00392782
      occurrences
      1. context exact
        NCT00392782
        end
        11
        exact text
        NCT00392782
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Chronic Myeloid Leukemia
      query disease state id
      ds-chronic-myeloid-leukemia-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-chronic-myeloid-leukemia-000.json
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      source json pointer
      /studies/28/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e613b7c3cbdd2903d53dfa38ea99d60f10b39c57dc18f5c47ab431fe29141d07

    Preserved source evidence · Not medical advice