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Trial record 46 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Haploidentical Stem Cell Transplantation With CD3/CD19 Depletion and Reduced Intensity Conditioning in Patients With Acute Leukemia (CD3/CD19 Haplo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00961142
Recruitment Status : Terminated (slow recruitment)
First Posted : August 18, 2009
Last Update Posted : May 8, 2018
Information provided by (Responsible Party):
Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen

Brief Summary:
Feasibility and toxicity of haploidentical allogeneic HCT after a reduced intensity conditioning regimen with CD3/CD19 depleted grafts. This study enrolls patients with acute leukemia in complete remission with an indication for allogeneic HCT but without a suitable HLA-identical donor

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Drug: Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts After a Reduced Intensity Conditioning Regimen for Adult Patients With Acute Leukemia
Study Start Date : June 2009
Actual Primary Completion Date : December 30, 2015
Actual Study Completion Date : December 30, 2015

Intervention Details:
  • Drug: Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG)
    Conditioning with Fludarabine 30 mg/m2/24h day-8 to -4, Thiotepa 2x5 mg/kg day -3, Melphalan 60 mg/m2 day -2 to -1 and Thymoglobuline (ATG)1.5mg/kg/day day -9 to -6. PBSC depleted of CD3 and CD19 cells by immunomagnetic depletion on CliniMACS.

Primary Outcome Measures :
  1. Evaluation of treatment related mortality after haploidentical HCT [ Time Frame: 1 year after HCT ]
    Cumulative Incidence of treatment related mortality

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1, 2 and 5 years after inclusion ]
    by Kaplan-Meier

  2. Evaluate Engraftment [ Time Frame: One year after HCT ]
  3. Evaluate Toxicity [ Time Frame: One year after HCT ]
  4. Evaluate Disease Free Survival [ Time Frame: 1, 2 and 5 years after inclusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with either ALL or AML in CR with an indication for allogeneic HCT according to the following criteria:
  • AML: high risk patients with one or more of the following risk factors:

    • FLT-3 mutation
    • Complex cytogenetics
    • abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p)
    • Late CR > induction I
    • Age >60
    • Patients in 2.CR
    • Secondary AML
    • Relapse after a preceding allogeneic HCT from an HLA-identical donor
  • ALL: high risk patients with one or more of the following risk factors:

    • Pro-B-ALL
    • Initial WBC >30.000/µL
    • CR after day 46 after Induction II
    • Complex cytogenetics, t(9,22), t(4,11)
    • Early or mature T-ALL
    • Initially refractory patients with late CR
    • Rising MRD level
    • Patients in 2. CR
    • Relapse after a preceding allogeneic HCT from an HLA-identical donor
    • No HLA-identical donor (not more than 1 antigen mismatch (9/10-Match) or more than 2 allelic mismatches by high-resolution typing). Critical cases should be discussed with the PI.
    • Age <=65, >=18 years
    • Karnofsky Index >60%

Exclusion Criteria:

  • Patients with >5% blasts in BM at the time of transplantation
  • Less than 3 months after preceding HCT
  • CNS involvement with disease
  • History of neurologic impairment such as: seizures, severe peripheral neuropathy, signs of leukoencephalopathy, CNS infection, multiple intrathecal chemotherapies, CNS irradiation. In case of heavy pretreatment with irradiation or intrathecal chemotherapy pretransplant CNS MRI and neurological consultation are mandatory
  • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
  • Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher 2x upper limit of normal.
  • Chronic active viral hepatitis
  • Ejection fraction <40 % on echocardiography
  • Patients with > grade II hypertension by CTC criteria
  • Creatinine clearance <50 ml/min
  • Respiratory failure necessitating supplemental oxygen or DLCO <30%
  • Allergy against murine antibodies
  • HIV-Infection
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
  • Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
  • Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
  • Patients unwilling or unable to comply with the protocol
  • Unable to give informed consent
  • Enrollment in an other trial interfering with the endpoints of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00961142

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University of Dresden Medical Center
Dresden, Germany, D-01307
Center for Marrow Transplantation, University of Essen
Essen, Germany, 45122
Medical Center University of Halle
Halle, Germany, 06120
Medical Center University of Hamburg
Hamburg, Germany, 20246
Medical Center University of Muenster
Muenster, Germany, 48149
South West German Cancer Center, University of Tuebingen Medical Center
Tuebingen, Germany, 72076
Deutsche Klinik für Diagnostik
Wiesbaden, Germany, 65191
University of Wuerzburg Medical Center
Wuerzburg, Germany, D-97070
Sponsors and Collaborators
University Hospital Tuebingen
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Principal Investigator: Wolfgang A. Bethge, MD Medical Center University Hospital Tuebingen

Additional Information:
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Responsible Party: Prof. Dr. med. Wolfgang Bethge, Prof. Dr., University Hospital Tuebingen Identifier: NCT00961142     History of Changes
Other Study ID Numbers: EudraCT 2007-006016-33
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen:
Haploidentical Transplantation
CD3/CD19 Depletion
Reduced Intensity Conditioning
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists