|
Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid 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 Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia Clinical research trials and Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid 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 Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid 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 Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid 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.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia  Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
For Condition: adult acute differentiated monocytic leukemia (M5b),untreated adult acute myeloid leukemia,adult acute myelomonocytic leukemia (M4),adult acute myeloblastic leukemia with maturation (M2),adult acute megakaryocytic leukemia (M7),adult acute minimally differentiated myeloid leukemia (M0),adult acute erythroleukemia (M6),adult acute myeloblastic leukemia without maturation (M1),secondary acute myeloid leukemia,adult acute poorly differentiated monocytic leukemia (M5a)
Status: No longer recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia.
Details: OBJECTIVES: I. Determine the feasibility, toxicity, and antileukemic activity of gemtuzumab ozogamicin (CMA-676) with or without mitoxantrone, etoposide, cytarabine, and idarubicin in elderly patients with acute myeloid leukemia. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to risk (standard risk, defined as age 61-75 and WHO performance status 0-1 vs poor risk, defined as over 75 years and WHO performance status 0-2 OR under 76 years and WHO performance status 2). Frontline therapy: Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Stratum I (Standard risk patients): Patients with disease progression at any time during frontline therapy may begin induction therapy immediately. Induction therapy begins 7-10 days after response assessment regardless of response and in the absence of unacceptable toxicity. Stratum II (Poor risk patients): Patients experiencing complete remission with or without platelet recovery will begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity. Stratum I Induction therapy: Patients receive mitoxantrone IV over 30 minutes on days 1, 3 and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-7. Patients experiencing partial response are given a second induction therapy course. Patients experiencing complete remission with or without platelet recovery after 1 or 2 induction courses begin consolidation therapy within 4-8 weeks of response assessment in the absence of unacceptable toxicity. Consolidation therapy: Patients receive idarubicin IV on days 1, 3 and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-5. Stratum II Consolidation therapy: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and then 1-3 months later. Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 45-82 (28-49 for stratum I, and 17-33 for stratum II) patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 61 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of primary or secondary acute myeloid leukemia (AML); Previously untreated; At least 20% marrow blasts AML after myelodysplastic syndrome allowed; No leukemia after other myeloproliferative diseases; No acute promyelocytic leukemia (M3) or blastic phase chronic myelogenous leukemia - No active CNS leukemia --Prior/Concurrent Therapy-- - Biologic therapy: No prior humanized monoclonal antibody therapy - Chemotherapy: Up to 7 days of prior hydroxyurea allowed; At least 24 hours since prior hydroxyurea; No other prior chemotherapy for AML - Endocrine therapy: No more than 7 days of prior corticosteroids; No other prior endocrine therapy - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 61 and over - Performance status: WHO 0-2 - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics; White blood count no greater than 30,000/mm3 unless reducible to less than 30,000/mm3 by a maximum of 7 days of hydroxyurea - 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 that would preclude study - Pulmonary: No severe lung failure that would preclude study - Other: No other concurrent malignancies; No active uncontrolled infection; No concurrent severe neurological or psychiatric disease; No psychological, familial, sociological or geographical condition that would preclude compliance with study; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SergioAmadori, Study Chair, EORTC Leukemia Cooperative Group
Hotel Dieu de Paris
Paris, , 75181
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Ospedale Generale Regionale
Bolzano, , 39100
Italy
CHU Sart-Tilman
LIEGE, , B-4000
Belgium
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , 00168
Italy
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
University Hospital Rebro
Zagreb, , 41000
Croatia
A.Z. St. Jan
Brugge, , 8000
Belgium
Hopital Edouard Herriot
Lyon, , 69437
France
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Hopital Necker
Paris, , 75743
France
Ospedali Riuniti
Reggio Calabria, , 89100
Italy
Eberhard Karls Universitaet
Tuebingen, , D-72076
Germany
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Ospedale San Eugenio
Rome, , 00144
Italy
Azienda Policlinico Umberto Primo
Rome, , 00161
Italy
Medizinische Klinik und Poliklinik
Heidelberg, , D-69115
Germany
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , 5211 NL
Netherlands
Additional Information:
Study ID Numbers: CDR0000068137; EORTC-06993-AML-15
Study Start Date: June 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006122
Other Adult Acute Megakaryocytic Leukemia (m7) Studies:
1. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
2. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
3. Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
4. Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
5. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute megakaryocytic leukemia (M7) Clinical Trials
Other Clinical Trials
Other Reggio Calabria Clinical Trials
Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
|
|
|
|
|
|
|
|
