Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-96015A1 | |||
| NCI-V96-0881 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating institution and antecedent lymphoid blast crisis of chronic myelogenous leukemia (yes vs no). Patients are randomized to one of two treatment arms.
Arm I:
Arm II:
Treatment continues in patients achieving complete response. Patients in both arms receive alternating sequences of maintenance therapy over 2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARA-C/High-Dose Mitoxantrone("All-2") | Experimental | See detail description |
|
| Standard Vincristine/Prednisone ("L-20") | Active Comparator | See detail description |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dactinomycin | Biological |
| ||
| sargramostim |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) | complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia. | 2 years |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of one of the following malignancies:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole Lamanna, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1678 | United States | ||
| Stanford Cancer Center at Stanford University Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All-2 | ARA-C/High-Dose Mitoxantrone("All-2") Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
|
| carmustine | Drug |
|
| cyclophosphamide | Drug |
|
| cytarabine | Drug |
|
| daunorubicin hydrochloride | Drug |
|
| doxorubicin hydrochloride | Drug |
|
| etoposide | Drug |
|
| mercaptopurine | Drug |
|
| methotrexate | Drug |
|
| mitoxantrone hydrochloride | Drug |
|
| pegaspargase | Drug |
|
| prednisone | Drug |
|
| vincristine sulfate | Drug |
|
| radiation therapy | Radiation |
|
| Stanford |
| California |
| 94305-5750 |
| United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| FG001 |
| L-20 |
Standard Vincristine/Prednisone ("L-20") Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All-2 | ARA-C/High-Dose Mitoxantrone("All-2") |
| BG001 | L-20 | Standard Vincristine/Prednisone ("L-20") |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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) | complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia. | Posted | Number | participants | 2 years |
|
|
|
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 | All-2 | ARA-C/High-Dose Mitoxantrone("All-2") | 39 | 81 | 49 | 81 | ||
| EG001 | L-20 | Standard Vincristine/Prednisone ("L-20") | 33 | 89 | 42 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adult respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Abdominal pain/cramping | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Acidosis | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Amylase | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Ataxia | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Bilirubin | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Blood,Bone marrow,other | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Bone pain | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Cardiac left ventricle | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Cardiovascular, other | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Colitits | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Dysphagia, esophagitis | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Febrile neutropenia | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Fever | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Fibrinogen | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Hand-Foot Skin reaction | Skin and subcutaneous tissue disorders | CTC-2.0 | Systematic Assessment |
| |
| Headache | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Hematuria | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Hemorrhage, other | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Hepatic enlargement | Renal and urinary disorders | CTC-2.0 | Systematic Assessment |
| |
| Hepatic, other | Renal and urinary disorders | CTC-2.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Ileus (or neuroconstipation) | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| infection | Infections and infestations | CTC-2.0 | Systematic Assessment |
| |
| Infection with grade 3/4 neutrophils | Infections and infestations | CTC-2.0 | Systematic Assessment |
| |
| Infection/Febrible Neutrophil-Other | Infections and infestations | CTC-2.0 | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTC-2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Neurology, other | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Neutrophils (Leukemia) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Pain, other | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Pulmonary, other | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC-2.0 | Systematic Assessment |
| |
| SGOT (AST) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| SGPT (ALT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Syncope | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTC-2.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Thrombosis | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Supravent arrhythmia | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Stomatitis/pharyngitis | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Gastrointestinal, other | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Epistaxis | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Dermatology, skin other | Skin and subcutaneous tissue disorders | CTC-2.0 | Systematic Assessment |
| |
| Dehydration | General disorders | CTC-2.0 | Systematic Assessment |
| |
| disseminated intravascular coagulation | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Chest pain | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Cardiovascular, Arrhythmia other | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Ascites | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| ALT, SGPT | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain/cramping | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Anorexia | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Bilirubin | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Bone pain | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Febrile neutropenia | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Insomnia | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Muscle weakness | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Pain, other | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Prothrombin Time | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Rigors, chills | General disorders | CTC-2.0 | Systematic Assessment |
| |
| SGPT (ALT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Stomatitis/pharyngitis | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Thrombosis | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTC-2.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Maslak | Memorial Sloan Kettering Cancer Center | 212-639-5518 | maslakp@mskcc.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D001752 | Blast Crisis |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
Not provided
Not provided
| ID | Term |
|---|---|
| D003609 | Dactinomycin |
| C081222 | sargramostim |
| D002330 | Carmustine |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D015122 | Mercaptopurine |
| D008727 | Methotrexate |
| D008942 | Mitoxantrone |
| C042705 | pegaspargase |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Failure |
|
| Failure-Progression |
|
| Relapse |
|