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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-01142 | |||
| NCI-G02-2069 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Bristol-Myers Squibb | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.
OUTLINE: Patients are stratified according to risk (low-intermediate vs high-intermediate or high).
Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV over 15 minutes, and vincristine IV over 1-2 minutes on day 1; oral prednisone once daily on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) once daily on days 7-11 or PEG-filgrastim once at least 24 hours after infusion. Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy. Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
After the completion of induction chemotherapy, patients undergo CT scan and positron emission tomography (PET) scanning. If the PET scan is positive in one or more nodal sites, a repeat biopsy is performed. Patients with a negative PET scan OR a negative repeat biopsy (including no evidence of lymphoma on repeat bone marrow biopsy) are assigned to receive regimen A for consolidation therapy. Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy.
Patients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation. All patients are followed closely for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 40-98 patients will be accrued for this study within 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction R-CHOPac Therapy for patients with B-Cell Lymphoma | Experimental | Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Kaplan-Meier estimates will be used to verify the progression free survival. | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed aggressive diffuse large B-cell lymphoma
CD20-positive disease
Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:
Positron emission tomography avid measurable disease
No CNS involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Moskowitz, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38271621 | Derived | Bantilan KS, Smith AN, Maurer MJ, Teruya-Feldstein J, Matasar MJ, Moskowitz AJ, Straus DJ, Noy A, Palomba ML, Horwitz SM, Hamlin PA, Portlock CS, Cerhan JR, Habermann TM, Salles GA, Nowakowski GS, Moskowitz CH, Zelenetz AD. Matched control analysis suggests that R-CHOP followed by (R)-ICE may improve outcome in non-GCB DLBCL compared with R-CHOP. Blood Adv. 2024 May 14;8(9):2172-2181. doi: 10.1182/bloodadvances.2023011408. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction R-CHOPac Therapy | Induction R-CHOPac Therapy for patients with B-Cell Lymphoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
| carboplatin | Drug |
|
| cyclophosphamide | Drug |
|
| doxorubicin hydrochloride | Drug |
|
| etoposide | Drug |
|
| ifosfamide | Drug |
|
| prednisone | Drug |
|
| vincristine sulfate | Drug |
|
| peripheral blood stem cell transplantation | Procedure |
|
| radiation therapy | Radiation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Induction R-CHOPac Therapy | Induction R-CHOPac Therapy for patients with B-Cell Lymphoma |
| 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 |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Progression Free Survival | Kaplan-Meier estimates will be used to verify the progression free survival. | Posted | Number | 95% Confidence Interval | percentage of patients progression free | 2 years |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Induction R-CHOPac Therapy | Induction R-CHOPac Therapy for patients with B-Cell Lymphoma | 20 | 98 | 98 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain/cramping | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Arachnoiditis | Musculoskeletal and connective tissue disorders | CTC-2.0 | Systematic Assessment |
| |
| Constitutional symptoms, other | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Delusions | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Febrile neutropenia | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Fever | General disorders | CTC-2.0 | Systematic Assessment |
| |
| GI, other | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Headache | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Hemorrhage, other | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Ileus (or neuroconstipation) | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTC-2.0 | Systematic Assessment |
| |
| Radiation mucositis | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Pain - Stomach | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Pulmonary, other | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Supravent arrhythmia | Cardiac disorders | CTC-2.0 | Systematic Assessment |
| |
| Syncope | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Thrombosis | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Bilirubin | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition 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 |
| |
| Infection without neutropenia | Infections and infestations | CTC-2.0 | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Prothrombin time (PT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Partial thromboplastin time (PTT) | Blood and lymphatic system 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 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Moskowitz | Memorial Slaon Kettering | 212-639-7992 | moskowic@mskcc.org |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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