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Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical research trials and Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia. Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia  Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
For Condition: untreated adult acute lymphoblastic leukemia,stage 1 adult lymphoblastic lymphoma,stage 3 adult lymphoblastic lymphoma,stage 4 adult lymphoblastic lymphoma,contiguous stage 2 adult lymphoblastic lymphoma,noncontiguous stage 2 adult lymphoblastic lymphoma
Status: No longer recruiting
Sponsor(s): EORTC Leukemia Cooperative Group , Leucemies Aigues et Lymphomes de l'Adulte
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy. PURPOSE: Randomizedphase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.
Details: OBJECTIVES: - Compare the remission induction, toxicity, and duration of remission in patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma treated with prednisone vs dexamethasone plus cyclophosphamide, daunorubicin, and vincristine as induction. - Compare the survival and disease-free survival of patients treated with autologous bone marrow transplantation (BMT) followed by low- or high-intensity maintenance chemotherapy with cranial irradiation after consolidation. - Determine the relative and disease-free survival of patients treated with autologous or allogeneic BMT after identical induction, consolidation, and conditioning regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and risk group (high vs standard). Induction - Patients are randomized to 1 of 2 treatment arms. - Arm I:Patients receive daunorubicin IV on days 1-3 and 15 and 16; cyclophosphamide (CTX) IV on days 1 and 8; vincristine (VCR) IV on days 1, 8, 15, and 22; and prednisone IV or orally every 8 hours on days 1-7 and 15-21. - Arm II: Patients receive daunorubicin, CTX, and VCR as in arm I and dexamethasone IV or orally on days 1-8 and 15-22. - Patients on both arms without CNS disease at presentation receive CNS prophylaxis comprising methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22. Patients on both arms with CNS disease at presentation receive CNS therapy comprising hydrocortisone (HC) IT and MTX IT alternating with cytarabine (ARA-C) IT twice a week until CSF clears. After induction, patients on both arms proceed to consolidation, regardless of response. Consolidation - Patients receive ARA-C IV over 2 hours every 12 hours on days 29-34 and mitoxantrone IV on days 33-35. Patients without CNS disease at presentation receive CNS prophylaxis comprising MTX IT on day 29. Patients with CNS disease at presentation receive CNS therapy comprising HC IT and MTX IT alternating with ARA-C weekly for 6 weeks. Patients who achieve complete response (CR) at day 55-60 receive MTX IV on days 64 and 79, leucovorin calcium IV or orally every 6 hours on days 65-67 and 80-82, and asparaginase IV over 1 hour or intramuscularly on days 65 and 80. - Standard-risk patients who are under age 20 and achieve CR after day 80 are assigned to arm IV of group A. Patients who achieve CR after day 80 and have a genotypically or phenotypically HLA-matched family donor, a family donor mismatched at only 1 locus (A, B, or DR), or an HLA-matched unrelated donor proceed to group B. Patients who achieve CR after day 80 and are eligible for autologous bone marrow transplantation (BMT) proceed to group A. Patients found to be at extremely high risk are taken off study. Group A - Patients are randomized to 1 of 2 treatment arms. - Arm III: Autologous bone marrow is harvested. Patients receive bone marrow ablation comprising CTX IV over 1 hour on days -4 and -3 and total body irradiation on day -1. Autologous bone marrow is reinfused on day 0. Beginning at month 8 (4 months after BMT), patients receive first maintenance comprising VCR IV, doxorubicin IV, and dexamethasone IV (VAD) or VCR IV, doxorubicin IV, and prednisolone IV (VAP) on days 1-4 and 29-32. Patients receive second maintenance comprising oral mercaptopurine daily and oral MTX daily beginning at month 10 and continuing through year 3. Patients without CNS disease at presentation receive CNS prophylaxis comprising MTX IT on days 1 and 29. Patients with CNS disease at presentation receive CNS therapy comprising ARA-C IT, MTX IT, and HC IT beginning at 1 month after BMT and continuing monthly for 1 year and then every 3 months through year 3. - Arm IV: Patients receive CTX IV and ARA-C IV continuously on day 1, oral mercaptopurine on days 8-28, and oral MTX on days 8, 15, and 22 during months 4, 7, 11, 13, 17, 21, 25, and 29. Patients receive MTX IV over 30 minutes on day 1, leucovorin calcium IV or orally every 6 hours on days 2-4, asparaginase IV over 1 hour or intramuscularly on day 2, oral mercaptopurine on days 8-28, and oral MTX on days 8, 15, and 22 during months 6, 10, 12, 15, 19, 23, and 27. Patients receive VAD or VAP as in arm III beginning at month 8. Patients without CNS disease at presentation receive CNS prophylaxis comprising whole brain radiotherapy and MTX IT on day 1 of radiotherapy during month 5. Patients with CNS disease at presentation receive CNS therapy as in arm III. Group B - Allogeneic bone marrow is harvested. Patients receive bone marrow ablation as in arm III beginning on day 100. Allogeneic bone marrow is infused over 15-30 minutes on day 0. - Patients in groups A and B with CNS disease at presentation undergo radiotherapy to focal infiltration at entry or concurrently with total body irradiation, or whole brain radiotherapy during maintenance (if no prior CNS irradiation). At any time during the study, patients who develop marrow relapse (more than 5% leukemic blasts in bone marrow on 2 occasions), CNS relapse (blasts in CSF, cranial nerve palsy, or CNS mass), or testis or other extramedullary relapse are taken off study. PROJECTED ACCRUAL: A total of 392 patients will be accrued for this study within approximately 6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma with more than 30% blasts in bone marrow PATIENT CHARACTERISTICS: Age: - 15 to 60 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 2 mg/dL (unless elevation due to leukemic involvement of liver) Renal: - Creatinine less than 2 mg/dL (unless elevation due to leukemic involvement of kidneys) Cardiovascular: - No severe cardiac disease Pulmonary: - No severe pulmonary disease Other: - No severe neurologic or metabolic disease - HIV negative (if tested) - No other prior malignancy except nonmelanomatous skin cancer, stage I cervical carcinoma, or other curatively treated malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - No prior endocrine therapy Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoelWillemze, Study Chair, Leiden University Medical Center
Ospedale Gen. Provinciale Santa Maria Goretti
Latina, , 04100
Italy
Ospedale Di Montefiascone
Montefiascone, , I-01027
Italy
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 HA
Netherlands
Ospedale Ferrarotto
Catania, , 95124
Italy
Hotel Dieu de Paris
Paris, , 75181
France
University Hospital Rebro
Zagreb, , 10000
Croatia
Kreiskrankenhaus Meissen
Meissen, , D-01662
Germany
Centre Medico-Chirurgical Foch
Suresnes, , 92151
France
C.H.U. Saint-Pierre
Brussels, , 1000
Belgium
Ospedal SS Annunziata
Taranto, , 74100
Italy
Algemeen Ziekenhuis Middelheim
Antwerpen, , B-2020
Belgium
Ospedale S. Gennaro ASL NA1
Naples (Napoli), , 80136
Italy
Policlinico Monteluce
Perugia, , 06122
Italy
Policlinico di Careggi
Firenze (Florence), , 50134
Italy
Hopital Necker
Paris, , 75743
France
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Ospedali Riuniti Foggia
Foggia, , 71100
Italy
Ospedale San Carlo
Potenza, , 85100
Italy
Ospedale S. Antonio Abate
Gallarate Varese, , 21013
Italy
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Ospedale Santa Croce
Cuneo, , 12100
Italy
A. Perrino Hospital
Brindisi, , 72100
Italy
Institute of Hematology & Transfusiology, University Hospital
Bratislava, , 85107
Slovakia
Policlinico - Cattedra di Ematologia
Palermo, , 90100
Italy
University Hospital - Olomouc
Olomouc, , 775 20
Czech Republic
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , 5211 NL
Netherlands
Ospedale Molinette
Turin (Torino), , 10126
Italy
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , 71013
Italy
Medical School/University of Zagreb
Zagreb (Agram), , 10000
Croatia
Ospedale Civile Avellino
Avellino, ,
Italy
Istituto di Ematologia Universita - University di Sassari
Sassari, , 07100
Italy
Universita Degli Studi di Bari Policlinico
Bari, , 70124
Italy
A.Z. St. Jan
Brugge, , 8000
Belgium
Ospedale Maggiore Lodi
Lodi, , I-20075
Italy
Centre Hospitalier Peltzer-La Tourelle
Verviers, , B-4800
Belgium
Maxima Medisch Centrum - locatie Eindhoven
Eindhoven, , 5631 BM
Netherlands
Ibn-i Sina Hospital
Ankara, , 06100
Turkey
Hopital Edouard Herriot
Lyon, , 69437
France
Hospital Escolar San Joao
Porto, , 4200
Portugal
CHU Sart-Tilman
LIEGE, , B-4000
Belgium
Ospedale Regionale A. Pugliese
Catanzaro, , 88100
Italy
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Ospedale Civile Alessandria
Alessandria, , I-15100
Italy
Additional Information:
Study ID Numbers: CDR0000064498; EORTC-06951,FRE-LALA-94
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002700
Other Stage 1 Adult Lymphoblastic Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
2. Combination Chemotherapy in Treating Adults With Acute Lymphocytic Leukemia
3. Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
4. Diagnostic Study of Patients With Acute Lymphoblastic Leukemia
5. Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes
Related Studies:
Other stage 1 adult lymphoblastic lymphoma Clinical Trials
Other Clinical Trials
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Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
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