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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia  Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
For Condition: adult acute myelomonocytic leukemia (M4),untreated adult acute myeloid leukemia,adult acute differentiated monocytic leukemia (M5b),adult acute myeloblastic leukemia without maturation (M1),Neutropenia,adult acute myeloblastic leukemia with maturation (M2),adult acute minimally differentiated myeloid leukemia (M0),secondary acute myeloid leukemia,adult acute poorly differentiated monocytic leukemia (M5a),adult acute megakaryocytic leukemia (M7),adult acute erythroleukemia (M6)
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. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in the bone marrow or peripheral blood and may help a person's immune system recover after chemotherapy and radiation therapy. Combining more than one drug and giving drugs in different ways may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without G-CSF in treating older patients with acute myeloid leukemia.
Details: OBJECTIVES: I. Assess the role of granulocyte colony-stimulating factor given during and/or after remission induction with MICE (mitoxantrone/cytarabine/etoposide) in elderly patients with acute myelogenous leukemia (AML). II. Compare the complete remission (CR) rate and survival of these patients when treated with nearly equivalent doses of oral vs. intravenous mini-ICE (idarubicin/cytarabine/etoposide) as consolidation therapy given on an outpatient basis. III. Evaluate the feasibility of a second intensive consolidation regimen consisting of BAVC (carmustine/amsacrine/etoposide/cytarabine) followed by autologous stem cell support in patients under age 71 who are in CR and have good performance status. PROTOCOL OUTLINE: Randomized study. All patients are randomly assigned to Arms IA through ID for Induction. Patients who achieve CR and who have adequate organ function and performance status are then randomly assigned to Arm IIA or IIB for Consolidation. At selected centers, patients in CR after their first Consolidation course who are under age 71 and in very good clinical condition are treated on Regimen A (in lieu of a second Consolidation course). The following acronyms are used: AMSA Amsacrine, NSC-249992 ARA-C Cytarabine, NSC-63878 BAVC BCNU/AMSA/VP-16/ARA-C BCNU Carmustine, NSC-409962 DHAD Mitoxantrone, NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor (Rhone-Poulenc Rorer) IDA Idarubicin, NSC-256439 MICE DHAD/ARA-C/VP-16 Mini-ICE IDA/ARA-C/VP-16 PBSC Peripheral Blood Stem Cells VP-16 Etoposide, NSC-141540 INDUCTION: Arm IA: 3-Drug Combination Chemotherapy. MICE. Arm IB: 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF during chemotherapy. Arm IC: 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF after chemotherapy. Arm ID: 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF during and after chemotherapy. CONSOLIDATION: Arm IIA: 3-Drug Combination Chemotherapy. Mini-ICE. Intravenous IDA/VP-16/ARA-C. Arm IIB: 3-Drug Combination Chemotherapy. Mini-ICE. Oral IDA/VP-16 + subcutaneous ARA-C. Regimen A: Stem Cell Mobilization followed by 4-Drug Combination Myeloablative Chemotherapy with Stem Cell Rescue. G-CSF; followed by BAVC; with PBSC. PROJECTED ACCRUAL: 500 patients will be randomized for Induction, of whom an anticipated 238 patients will be randomized for Consolidation. If at interim analyses survival is shorter on Regimen A, that regimen will be closed.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 61 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Acute myeloblastic leukemia (AML); At least 30% blast cells in bone marrow smear Secondary AML eligible, as follows: Secondary to myelodysplastic syndrome (but not other myeloproliferative diseases); Secondary to cured Hodgkin's disease or other cured malignancy; Secondary to alkylating agents or radiation for other reasons - Acute promyelocytic leukemia (M3) referred to the collaborative Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto-EORTC protocol (EORTC-06952) - No blast crisis of chronic myeloid leukemia --Prior/Concurrent Therapy-- - No prior chemotherapy --Patient Characteristics-- - Age: 61 to 80 - Performance status: WHO 0-2 - Life expectancy: No marked impairment from disease other than AML - Hematopoietic: Not applicable - Hepatic: Bilirubin less than 2 x ULN - Renal: Creatinine less than 2 x ULN - Cardiovascular: LVEF at least 50%; No severe cardiac disease - Pulmonary: No severe pulmonary disease - Other: HIV seronegative (if tested); No uncontrolled infection; No severe neurologic, metabolic, or psychiatric disease; No other concomitant disease that precludes protocol therapy; No other progressive malignant disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TheoWitte, Study Chair, EORTC Leukemia Cooperative Group
Azienda Policlinico Umberto Primo
Rome, , 00161
Italy
Additional Information:
Study ID Numbers: CDR0000064570; EORTC-06954
Study Start Date: December 1995
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002719
Other Adult Acute Myeloblastic Leukemia With Maturation (m2) Studies:
1. Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed Acute Leukemia
2. Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
3. FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
5. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Related Studies:
Other adult acute myeloblastic leukemia with maturation (M2) Clinical Trials
Other Clinical Trials
Other Rome Clinical Trials
Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
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