Description:

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia see http://clinicaltrials.gov/ct2/show/record/NCT00006045

Link:
http://clinicaltrials.gov/ct2/show/record/NCT00006045
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Versions (5)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 3/25/14 3/25/14 - Martin Dugas
  3. 4/11/14 4/11/14 - Julian Varghese
  4. 4/11/14 4/11/14 - Julian Varghese
  5. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
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April 13, 2021

DOI:
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Creative Commons BY 4.0
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Eligibility NCT00006045 AML

English
Details

Eligibility AML NCT00006045

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  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00006045
Disease Characteristics
Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
No transplantation candidates
Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
No active CNS leukemia
Patient Characteristics
Age: 18 and over
Karnofsky 50-100%
Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) C1522609
Creatinine less than 2.0 mg/dL (unless related to AML)
Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study negation
HIV negative
No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
Prior concurrent therapy
At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
No concurrent radiotherapy
No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
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