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Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia Clinical research trials and Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia. Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia  Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
For Condition: adult acute monocytic leukemia,adult acute myeloid leukemia
Status: Recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomizedphase III trial to study the effectiveness of combination chemotherapy, interleukin-2, and peripheral stem cell transplantation in treating patients who have acute myeloid leukemia.
Details: OBJECTIVES: - Compare the overall survival rate in patients with acute myeloid leukemia treated with high-dose versus standard-dose cytarabine during induction. - Compare the disease-free survival rate in patients treated with or without interleukin-2 following consolidation and autologous peripheral blood stem cell or bone marrow transplantation. - Compare the feasibility of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients in the first randomization are stratified according to center, WBC (no greater than 25,000/mm^3 vs 25,000-99,000/mm^3 vs at least 100,000/mm^3), age (15 to 45 vs 46 to 60), and performance status (0-1 vs 2 vs 3). Patients in the second randomization are stratified according to center, first treatment arm (I vs II), number of induction courses to reach complete remission (CR), cytogenic/molecular genetic group at diagnosis (low vs high vs intermediate vs unknown), and autologous peripheral blood stem cell (PBSC) transplantation planned after consolidation (yes vs no). First randomization - Patients are randomized to 1 of 2 treatment arms: - Arm I: Patients receive standard-dose cytarabine IV over 24 hours on days 1-10, etoposide IV over 1 hour on days 1-5, and daunorubicin IV over 5 minutes on days 1, 3, and 5. - Arm II: Patients receive etoposide and daunorubicin as in arm I and high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, 5, and 7. - Consolidation: When CR is reached, patients receive intermediate-dose cytarabine IV over 2 hours every 12 hours on days 1-6 and daunorubicin IV over 5 minutes prior to cytarabine on days 4, 5, and 6. - Harvest: Patients who achieve CR and are ineligible for allogeneic PBSC transplantation receive filgrastim (G-CSF) subcutaneously (SQ) every 12 hours beginning 20 days after starting consolidation treatment and continuing until autologous PBSC are harvested. Autologous bone marrow is collected from patients with insufficient PBSC. Allogeneic PBSC are harvested for patients who have an HLA identical donor. Allogeneic bone marrow is harvested for high risk patients (under age 40) who have an unrelated bone marrow donor. - Transplant preparative chemotherapy: It is recommended that patients receive cyclophosphamide on 2 consecutive days and total body irradiation on 3 days OR busulfan on days -8, -7, -6, and -5 followed by cyclophosphamide on days -4 and -3. - Transplantation: PBSC or bone marrow is infused on day 0. Second randomization - Patients who achieve CR with full hematologic recovery but have no HLA identical donor are randomized to 1 of 2 treatment arms no earlier than day 22 after stem cell infusion. - Arm I: Patients receive interleukin-2 SQ once daily for 5 days. Treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive no further treatment. Patients are followed at 1, 4, and 13 months, then every 4 months for 3 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 1,320 patients will be accrued for this study over 3.3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - First randomization: - Untreated newly diagnosed acute myeloid leukemia (AML) - At least 30% blasts in bone marrow - All cytological types of AML except acute promyelocytic leukemia (M3) - No blast crisis of chronic myelogenous leukemia - No leukemias supervening after other myeloproliferative disease - No leukemias supervening after overt myelodysplastic disorders (e.g., refractory anemia with excess blasts) for more than 6 months duration - Second randomization: - Must have achieved complete remission with full hematologic recovery following consolidation treatment - No HLA identical family donor - Not eligible for allograft - No high risk patient (under age 40) for whom an unrelated bone marrow donor has been found within 8 weeks of beginning consolidation treatment PATIENT CHARACTERISTICS: Age: - 15 to 60 Performance status: - WHO 0-3 (first randomization) - WHO 0-2 (second randomization) Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 3 times upper limit of normal (ULN) Renal: - Creatinine no greater than 3 times ULN Cardiovascular: - No severe heart failure requiring diuretics - Ejection fraction at least 50% Other: - First randomization: - No other progressive malignant disease except the following: - Secondary acute leukemias following curatively treated Hodgkin's disease (even if treated with anthracyclines) - Other curatively treated malignancies - Secondary leukemias following other exposure to alkylating agents or radiotherapy for other reason - No uncontrolled infection - No severe concurrent neurologic or psychiatric disease - No psychological, familial, sociological, or geographical condition that could preclude compliance - Second randomization: - No nonmalignant systemic illness that would increase risk of participation in study - No uncontrolled infection - No other progressive malignant disease PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for AML except hydroxyurea - Less than 7 days of prior hydroxyurea Endocrine therapy: - No more than 7 days of prior corticosteroid therapy for AML Radiotherapy: - No prior radiotherapy for AML Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoelWillemze, , Leiden University Medical Center
Ospedale S. Antonio Abate *Recruiting*
Gallarate Varese, , 21013
Italy
Recruiting Contact Person 39-331-751-3059
Institute of Hematology and Blood Transfusion *Recruiting*
Prague, , 128 20
Czech Republic
Recruiting Contact Person 420-2-2492-2265
Ospedale Casa Sollievo della Sofferenza *Recruiting*
San Giovanni Rotondo, , 71013
Italy
Recruiting Contact Person 39-0882-410-021
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
Clinical Hospital Merkur *Recruiting*
Zagreb, ,
Croatia
Recruiting Contact Person 385-1-233-5236
Azienda Istituti Ospitalieri *Recruiting*
Cremona, , 26100
Italy
Recruiting Contact Person 39-372-405-258
Policlinico P. Giaccone - Universita Di Palermo *Recruiting*
Palermo, , 90127
Italy
Recruiting Contact Person 39-091-65-144
Ospedale Civile Alessandria *Recruiting*
Alessandria, , I-15100
Italy
Recruiting Contact Person 39-131-206-111
Universita di Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Contact Person 39-11-670-5955
Ospedale San Salvatore *Recruiting*
Pesaro, , I-61100
Italy
Recruiting Contact Person 39-0721-364-124
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-2-5553111
Azienda Ospedaliera Di Parma *Recruiting*
Parma, , 43100
Italy
Recruiting Contact Person 39-521-290-787
Ospedale Civile Pescara *Recruiting*
Pescara, , 65100
Italy
Recruiting Contact Person 39-85-4521
Hopital Necker *Recruiting*
Paris, , 75743
France
Recruiting Contact Person 33-1-4449-4000
Azienda Policlinico Umberto Primo *Recruiting*
Rome, , 00161
Italy
Recruiting Franco Mandelli 39-06-857-951
Centre Hospitalier Regional de la Citadelle *Recruiting*
LIEGE, , 4000
Belgium
Recruiting Contact Person 32-4-2256111
Ospedale Santa Croce *Recruiting*
Cuneo, , 12100
Italy
Recruiting Contact Person 39-171-4411
Ospedali Riuniti Foggia *Recruiting*
Foggia, , 71100
Italy
Recruiting Contact Person 39-881-732-424
Ospedale San Carlo *Recruiting*
Potenza, , 85100
Italy
Recruiting Contact Person 39-0971-61-1111
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore *Recruiting*
Rome, , 00168
Italy
Recruiting Contact Person 39-63-0151
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-3-280-3111
H. San Giovanni-Addolorata Hospital *Recruiting*
Rome, , 00184
Italy
Recruiting Contact Person 39-6-7705-5500
Istituto Scientifico H.San Raffaele *Recruiting*
Milano, , 20132
Italy
Recruiting Contact Person 39-2-643-2653
Innsbruck Universitaetsklinik *Recruiting*
Innsbruck, , A-6020
Austria
Recruiting Contact Person 43-512-504-2970
Ospedale Cervello *Recruiting*
Palermo, , 90146
Italy
Recruiting Contact Person 39-096-802-111
A.Z. St. Jan *Recruiting*
Brugge, , 8000
Belgium
Recruiting Contact Person 32-50-452-800
Ospedale Di Montefiascone *Recruiting*
Montefiascone, , I-01027
Italy
Recruiting Contact Person 39-7-833-210
CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE, , B-4000
Belgium
Recruiting Contact Person 32-4-3667111
Hopital Edouard Herriot *Recruiting*
Lyon, , 69437
France
Recruiting Contact Person 33-4-7211-7300
Hotel Dieu de Paris *Recruiting*
Paris, , 75181
France
Recruiting Contact Person 33-1-4234-8413
Ospedale Sant' Eugenio *Recruiting*
Rome, , 00144
Italy
Recruiting Contact Person 39-6-5100-2569
Istituto Regina Elena *Recruiting*
Rome, , 00161
Italy
Recruiting Contact Person 39-65-2661
Ospedale Gen. Provinciale Santa Maria Goretti *Recruiting*
Latina, , 04100
Italy
Recruiting Contact Person 39-0773-657-667
Institute of Hematology & Transfusiology, University Hospital *Recruiting*
Bratislava, , 81103
Slovakia
Recruiting Contact Person 421-7-5441-2255
Ospedale Malacrino *Recruiting*
Reggio Calabria, , 89100
Italy
Recruiting Contact Person 39-965-397-111
Ospedale Oncologico A. Businco *Recruiting*
Cagliari, , 09124
Italy
Recruiting Contact Person 39-70-609-5204
Ospedale Regionale A. Pugliese *Recruiting*
Catanzaro, , 88100
Italy
Recruiting Contact Person 39-961-883-346
Jeroen Bosch Ziekenhuis *Recruiting*
NL'S Hertogenbosch, , NL-5211
Netherlands
Recruiting Contact Person 31-3173-616-2434
Ospedale S. Maria Sopra i Ponti *Recruiting*
Arezzo, , 52100
Italy
Recruiting Contact Person 39-575-305-368
Hospital Escolar San Joao *Recruiting*
Porto, , 4200
Portugal
Recruiting Contact Person 351-22-502-7151
Universita di Modena *Recruiting*
Modena, , 41100
Italy
Recruiting Contact Person 39-594-22-4373
Ospedale Generale Umberto 1 *Recruiting*
Ancona, , 60100
Italy
Recruiting Contact Person 39-71-5691
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-526911
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-8213000
Maxima Medisch Centrum - locatie Eindhoven *Recruiting*
Veldhoven, , 5500 MB DB
Netherlands
Recruiting Contact Person 31-40-258-8000
Istituto di Ematologia Universita - University di Sassari *Recruiting*
Sassari, , 07100
Italy
Recruiting Contact Person 39-79-228-280
University Hospital Rebro *Recruiting*
Zagreb, , 41000
Croatia
Recruiting Contact Person 385-1-233-3368
Ibn-i Sina Hospital *Recruiting*
Ankara, , 06100
Turkey
Recruiting Contact Person 90-312-310-3333 ext. 2132
Federico II University Medical School *Recruiting*
Naples (Napoli), , 80131
Italy
Recruiting Contact Person 39-81-746-2114
Centre Hospitalier Peltzer-La Tourelle *Recruiting*
Verviers, , B-4800
Belgium
Recruiting Contact Person 32-87-212111
Istituto Clinico Humanitas *Recruiting*
Rozzano (MI), , 20089
Italy
Recruiting Contact Person 39-822-445-56
Azienda Ospedaliera Papardo *Recruiting*
Messina, , 98100
Italy
Recruiting Contact Person 39-90-399-3491
Azienda Ospedale S. Luigi - Universita Di Torino *Recruiting*
Orbassano, (Torino), , 10043
Italy
Recruiting Contact Person 39-11-902-6511
Universita Degli Studi di Bari Policlinico *Recruiting*
Bari, , 70124
Italy
Recruiting Contact Person 39-80-547-8660
Additional Information:
Study ID Numbers: CDR0000067356; EORTC-06991
Study Start Date:
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004128
Other Adult Acute Monocytic Leukemia Studies:
1. Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
3. Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
4. Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
5. Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Related Studies:
Other adult acute monocytic leukemia Clinical Trials
Other Clinical Trials
Other Parma Clinical Trials
Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
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