Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-93139 | |||
| CHNMC-93139-94-03-1 | |||
| CDR0000564537 | Registry Identifier | NCI PDQ |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.
OBJECTIVES:
OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (idarubicin, cytarabine) | Experimental | Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytarabine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) | The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable. | 7 days post completion of induction chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Marrow at Day 7 Post-Induction Chemotherapy | Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%) | 7 days post completion of induction chemotherapy |
Not provided
DISEASE CHARACTERISTICS:
Inclusion criteria:
Newly diagnosed acute myeloid leukemia (AML)
Previously untreated with radiotherapy or chemotherapy
Patients with prior myelodysplastic syndrome are eligible
Extramedullary leukemia allowed
AML with lymphoid markers allowed
Exclusion criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony S. Stein, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | United States | ||
| City of Hope Comprehensive Cancer Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Idarubicin, Cytarabine) | All patients were analyzed together. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Idarubicin, Cytarabine) | All patients were analyzed together. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Remission (CR) | The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable. | Posted | Count of Participants | Participants | 7 days post completion of induction chemotherapy |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Idarubicin, Cytarabine) | All patients were analyzed together. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Stein, M.D. | City of Hope National Medical Center | 626-256-4673 | 82405 | AStein@coh.org |
Not provided
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| idarubicin | Drug |
|
|
| Duarte |
| California |
| 91010-3000 |
| United States |
| years |
|
| Gender | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
|
|
| Secondary | Bone Marrow at Day 7 Post-Induction Chemotherapy | Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%) | Posted | Count of Participants | Participants | 7 days post completion of induction chemotherapy |
|
|
|
| 51 |
| 111 |
| 95 |
| 111 |
| Skin | Skin and subcutaneous tissue disorders |
|
| Liver | Hepatobiliary disorders |
|
| Lung | Respiratory, thoracic and mediastinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Fever | General disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Hypertension | Vascular disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hypotension | Vascular disorders |
|
| Pancytopenia | Blood and lymphatic system disorders |
|
| Edema/Anasarca | Investigations |
|
| Gingivitis | Infections and infestations |
|
| Jaundice | Hepatobiliary disorders |
|
| Pancreatitis | Gastrointestinal disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Abdominal pain | Musculoskeletal and connective tissue disorders |
|
| Paresthesia | Nervous system disorders |
|
| Pleuritic Pain | Musculoskeletal and connective tissue disorders |
|
| Skin | Skin and subcutaneous tissue disorders |
|
| Mucositis | Gastrointestinal disorders |
|
| Renal | Renal and urinary disorders |
|
| Liver | Hepatobiliary disorders |
|
| Lung | Respiratory, thoracic and mediastinal disorders |
|
| Heart | Cardiac disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Fever | General disorders |
|
| Hemorrhage | Blood and lymphatic system disorders |
|
| Anxiety | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Fatigue | General disorders |
|
| Insomnia | Psychiatric disorders |
|
| Chills | General disorders |
|
| Edema | General disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
Not provided
Not provided
Not provided
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |