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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia  Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
For Condition: untreated adult acute myeloid leukemia,adult acute promyelocytic leukemia (M3)
Status: No longer recruiting
Sponsor(s): EORTC Leukemia Cooperative Group , Gruppo Italiano di Malattie Ematologiche Maligne de l'Aduklto-Associazione Italiana de Ematologia e Oncologia Pediatric
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.
Details: OBJECTIVES: I. Determine the complete remission (CR) rate in patients with acute promyelocytic leukemia treated with induction comprising tretinoin (ATRA) and idarubicin (IDA). II. Determine the presence of the promyelocyte-retinoic acid receptor alpha (PML-RARa) transcript using polymerase chain reaction (PCR) in patients with CR after 3 sequential consolidation regimens comprising cytarabine (ARA-C) plus IDA, followed by mitoxantrone plus etoposide, and then IDA, ARA-C, and thioguanine. III. Determine the percentage of patients who complete the protocol, including PML-RARa-positive patients treated with post-consolidation bone marrow transplantation (BMT) and PML-RARa-negative patients treated with maintenance comprising mercaptopurine (MP) plus methotrexate (MTX) vs ATRA only vs MP plus MTX alternating with ATRA vs observation only. IV. Compare the disease-free survival (DFS) and overall survival of these patients treated with these regimens. V. Determine the rate and type of grade 4 toxicity, treatment-related mortality, and time to granulocyte and platelet recovery associated with each phase of treatment in these patients. VI. Determine the DFS and overall survival of PML-RARa-positive patients who are ineligible for BMT and are treated with maintenance comprising MP plus MTX alternating with ATRA. VII. Compare the quality of life of patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Induction: Patients receive oral tretinoin (ATRA) twice daily beginning on day 1 and continuing for 30-90 days and idarubicin (IDA) IV over 15 minutes on days 2, 4, and 8. ATRA is discontinued before day 90 in the presence of complete remission (CR) at day 30 or 60, unacceptable toxicity, or disease progression or in the absence of at least a partial remission at day 60. Patients who achieve CR during induction proceed to consolidation. First consolidation: Within 2 weeks after achieving CR, patients receive cytarabine (ARA-C) IV over 6 hours followed 3 hours later by IDA IV over 15 minutes on days 1-4. Second consolidation: Within 4-6 weeks after initiation of first consolidation, patients receive mitoxantrone IV over 30 minutes and etoposide IV over 1 hour (beginning 12 hours after initiation of mitoxantrone infusion) on days 1-5. Third consolidation: Within 4-6 weeks after initiation of second consolidation, patients receive ARA-C subcutaneously every 8 hours and oral thioguanine every 8 hours on days 1-5 and IDA IV over 15 minutes on day 1. Patients proceed to group A if they are promyelocyte-retinoic acid receptor alpha (PML-RARa)-negative after recovery from third consolidation. Patients proceed to allogeneic bone marrow transplantation (BMT) on group B if they are PML-RARa-positive, achieve CR, are under age 55, and have an HLA-A, -B, and -DR identical, chronic myelomonocytic leukemia nonreactive, family donor after recovery from third consolidation. Patients proceed to autologous BMT on group B if they are PML-RARa-positive, achieve CR, and have no identical family donor or are age 55 and over after recovery from third consolidation. Patients proceed to arm III of group A if they are PML-RARa-positive and ineligible for BMT after recovery from third consolidation. Group A (maintenance): Patients are stratified according to participating center and initial white blood cell count. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive oral mercaptopurine (MP) daily and oral methotrexate (MTX) weekly. Arm II: Beginning 3 months after recovery from third consolidation, patients receive oral ATRA on days 1-15. Treatment on arms I and II continues every 3 months for 2 years in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive 1 course of arm I treatment, alternated by 1 course of arm II treatment. Alternating treatment continues every 3 months for 2 years in the absence of disease progression or unacceptable toxicity. Arm IV: Patients undergo observation only. Group B: Eligible patients receive conditioning comprising cyclophosphamide (CTX) IV for 2 days followed by total body irradiation or oral busulfan on days -9 to -6 and CTX on days -5 to -2. Autologous or allogeneic bone marrow is infused on day 0 (within 4 months after initiation of third consolidation). Quality of life is assessed at baseline, after induction, after each consolidation regimen, and then every 3 months beginning after treatment on group A or B. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 7.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/74 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed acute promyelocytic leukemia - Must have promyelocyte-retinoic acid receptor alpha transcript at disease presentation --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No concurrent cytotoxic chemotherapy - Endocrine therapy: Prior corticosteroids for leukemia allowed - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No prior antileukemic therapy --Patient Characteristics-- Age: 16 to 74 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: - Bilirubin no greater than 3 times upper limit of normal (ULN) - AST no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No cardiac contraindication to anthracycline chemotherapy Other: - No active serious infection not controlled by antibiotics - No severe concurrent psychiatric disease - No other malignancy except basal cell carcinoma - Not pregnant or nursing - Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PetraMuus, Study Chair, EORTC Leukemia Cooperative Group
Ospedale Regionale A. Di Summa
Brindisi, , I-72100
Italy
A.Z. St. Jan
Brugge, , 8000
Belgium
Ospedale Santa Croce
Cuneo, , 12100
Italy
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Istituto di Ematologia Universita - University di Sassari
Sassari, , 07100
Italy
Ospedale S. Antonio Abate
Gallarate Varese, , 21013
Italy
Hopital Necker
Paris, , 75743
France
Ospedale Ferrarotto
Catania, , 95124
Italy
Istituto Scientifico H.S. Raffaele
Milano, , 20132
Italy
Azienda Policlinico Umberto Primo
Rome, , 00161
Italy
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa (Genova), , 16132
Italy
Centre Medico-Chirurgical Foch
Suresnes, , 92151
France
Policlinico di Careggi
Firenze (Florence), , 50134
Italy
Leyenburg Ziekenhuis
's-Gravenhage (Den Haag, The Hague), , 2545 CH
Netherlands
Institut Jules Bordet
Brussels (Bruxelles), , 1000
Belgium
Ospedale Civile Avellino
Avellino, ,
Italy
Ospedale Civile Pescara
Pescara, , 65100
Italy
University Hospital Rebro
Zagreb, , 41000
Croatia
Medical School/University of Zagreb
Zagreb (Agram), , 41000
Croatia
Centre Hospitalier Regional de Lille
Lille, , 59037
France
Centre Hospitalier Peltzer-La Tourelle
Verviers, , B-4800
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
C.H.U. Saint-Pierre
Brussels (Bruxelles), , 1000
Belgium
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , 71013
Italy
Azienda Ospedaliera Di Parma
Parma, , 43100
Italy
Policlinico - Cattedra di Ematologia
Palermo, , 90100
Italy
Ospedale Civile Alessandria
Alessandria, , I-15100
Italy
Ospedale S. Gennora USL 42
Naples (Napoli), , 80136
Italy
Federico II University Medical School
Naples (Napoli), , 80131
Italy
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Ospedali Riuniti Foggia
Foggia, , 71100
Italy
Universita Degli Studi di Bari Policlinico
Bari, , 70124
Italy
Centro Trapianti di Midollo Osseo
Cremona, , 26100
Italy
Hotel Dieu de Paris
Paris, , 75181
France
Ospedal SS Annunziata
Taranto, , 74100
Italy
Ospedale San Francesco
Nuoro, , 08100
Italy
Onkologicka Klinka A Onkologicka Lab
Prague, , 128 08
Czech Republic
Ospedale Maggiore Ca Granda
Milano (Milan), , 20162
Italy
Centre Antoine Lacassagne
Nice, , 06189
France
Klinikum Grosshadern
Munich (Muenchen), , D-81377
Germany
Ospedale San Eugenio
Rome, , 00144
Italy
Ospedale Torrette University Ancona
Ancona, , 60020
Italy
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Ospedale Nuovo Pellegrini
Naples (Napoli), , 80144
Italy
Hopital Edouard Herriot
Lyon, , 69437
France
Ospedale San Salvatore
Pesaro, , I-61100
Italy
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Ospedale Maggiore Lodi
Lodi, , I-20075
Italy
Ospedale Oncologico A. Businco
Cagliari, , 09124
Italy
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Klinikum Duisburg
Duisburg, , D-47055
Germany
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Ospedale Regionale A. Pugliese
Catanzaro, , 88100
Italy
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Policlinico Monteluce
Perugia, , 06122
Italy
Institut Gustave Roussy
Villejuif, , F-94805
France
Azienda Ospedaliera "A. Cardarelli"
Naples (Napoli), , 80127
Italy
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
I.R.C.C.S. Policlinico San Matteo
Pavia, , 27100
Italy
Ospedale San Carlo
Potenza, , 85100
Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , 00168
Italy
Ospedale Molinette
Turin (Torino), , 10126
Italy
Cattedra di Immunologia Clinica
Turin (TO), , 10128
Italy
Ospedale Cervello
Palermo, , 90146
Italy
CHU Sart-Tilman
LIEGE, , B-4000
Belgium
Ibn-i Sina Hospital, Ankara University
Ankara, , 06100
Turkey
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , 5211 NL
Netherlands
Ospedale Di Montefiascone
Montefiascone, , I-01027
Italy
Ospedale Gen. Provinciale Santa Maria Goretti
Latina, , 04100
Italy
Additional Information:
Study ID Numbers: CDR0000064499; EORTC-06952
Study Start Date: October 1995
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002701
Other Adult Acute Promyelocytic Leukemia (m3) Studies:
1. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
2. Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes
3. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
4. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
5. FR901228 in Treating Patients With Hematologic Cancer
Related Studies:
Other adult acute promyelocytic leukemia (M3) Clinical Trials
Other Clinical Trials
Other Brussels (Bruxelles) Clinical Trials
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
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