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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01285 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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Manufacturing shortage of both Diftitox and Doxil
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
| Washington University School of Medicine | OTHER |
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This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.
This protocol proposes first to increase the proportion of patients who achieve adequate initial disease control and are able to proceed to autologous stem cell transplant (ASCT) in first complete or partial remission. It administers intensive and novel induction therapy.
Two cycles of gemcitabine, vinorelbine, Doxil (GND) will be used followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose methotrexate (MTX). Patients will be restaged after two cycles of GND to assess response to GND alone and again after the second cycle of augmented CHOP/high-dose MTX.
Those achieving a remission status will receive intensive consolidation with HiDAC/etoposide followed by stem cell mobilization. A five-day course of denileukin diftitox (Ontak) will be administered at and will serve as an in vivo purge. This will be followed by autologous stem cell transplant.
Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen will go on to consolidation/mobilization and autologous stem cell transplant.
Post-transplant, denileukin diftitox will also be used as an additional module of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Plan | Experimental | (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days (D) 1, 8, Navelbine 20 mg/m2 D1, D8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion (CIVI), days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion D0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Chemotherapy medication used to treat a number of types of cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial. | Up to 5 years |
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Inclusion Criteria:
Histologic diagnosis of any of the following:
Measurable or assessable disease is not required.
Age ≥ 18 and ≤ 70 years
Previously untreated or 1 prior cycle of chemotherapy
Creatinine < 2.0 mg/dL
Total bilirubin < 2.0 mg/dL, aspartate aminotransferase (AST) < 3x upper limit of normal
Patients who test positive for Hepatitis B surface Ag (HepBSAg) or Hepatitis C antibody (HepCAb) are eligible provided all of the following criteria are met:
Hepatitis B surface Ag(+) patients will be treated with lamivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Kaplan, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Plan | All patients will be given allopurinol 600 mg/day PO on day 1 of induction chemotherapy, and then 300 mg/day. Patients then receive two cycles of gemcitabine, vinorelbine, Doxil (GVD) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GVD and again after the second cycle of augmented CHOP/high-dose MTX. Those achieving a remission status received intensive consolidation with Idarubicin/cytosine arabinoside(iDAC)/etoposide followed by stem cell mobilization and 5-day course of denileukin diftitox (Ontak) will be administered followed by autologous stem cell transplant. Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen moved to consolidation/mobilization and autologous stem cell transplant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Navelbine | Drug | Navelbine is an chemotherapy medication used to treat a number of types of cancer |
|
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| Doxorubicin Hydrochloride Liposome Injection | Drug | Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug |
|
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| Granulocyte-colony stimulating factor (G-CSF) | Drug | G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. |
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| Pegfilgrastim | Drug | Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF |
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| Cyclophosphamide | Drug | Cancer medication that interferes with the growth and spread of cancer cells in the body |
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| Vincristine | Drug | Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer |
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| Leucovorin | Drug | Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer. |
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| Methotrexate | Drug | Methotrexate is a chemotherapy medication used to treat cancer |
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| Doxorubicin Hydrochloride | Drug | Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer |
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| Cytarabine | Drug | Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma |
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| Etoposide | Drug | Etoposide is a is a chemotherapy medication used to treat cancer |
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| Carmustine | Drug | Carmustine is a chemotherapy medication used to treat cancer |
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| Denileukin diftitox | Drug | Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells |
|
|
| Complete Response Rate | The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients. | Up to 3 years |
| Median Time to Response | The time to response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) in months. | Up to 2 years |
| Received GVD |
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| Received M-CHOP |
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| Evaluated Post Stem Cell Transplant |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Plan | (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1, 8, Granulocyte-colony stimulating factor(G-CSF) Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day 1-6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin diftitox |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Histology | Count of Participants | Participants |
| ||||||||||||||||||
| Extranodal Sites | Count of Participants | Participants |
| ||||||||||||||||||
| Disease Stage | The American Joint Committee on Cancer (AJCC) and the International Union for Cancer Control (UICC) maintain the classification system as a tool for doctors to stage different types of cancer based on certain standards. The stage refers to the extent of your cancer, such as how large the tumor is, and if it has spread. A cancer is always referred to by the stage it was given at diagnosis and is assigned a roman numeral from 0 to IV, where stage 0 is the least severe and stage 4 (IV) is the more severe and the cancer is more advanced than in the lower stages | Count of Participants | Participants |
| |||||||||||||||||
| Lactate Dehydrogenase (LDH)> normal | Count of Participants | Participants |
| ||||||||||||||||||
| International prognostic index (IPI) score | The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients. The score range is 0-5 with lower scores indicating a lower risk of death and higher scores indicating a greater risk of death. | Count of Participants | Participants |
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| 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 | Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy | Posted | Number | percentage of partcipants | Up to 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival Rate | Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial. | Posted | Number | percentage of participants | Up to 5 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Complete Response Rate | The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients. | Posted | Count of Participants | Participants | Up to 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Median Time to Response | The time to response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) in months. | Posted | Median | Full Range | months | Up to 2 years |
|
|
Up to 5 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 | Treatment Plan | (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5 | 7 | 21 | 21 | 21 | 11 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis/Bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver Function abnormalities | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
Enrollment was terminated prematurely due to manufacturing shortages of Doxil and Denileukin Diftitox (Ontak). All eligible patients who received at least one dose of study regimen were included in the analyses
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Kaplan, MD | University of California, San Francisco | (415) 353-2661 | LKaplan@ucsf.edu |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| C506643 | liposomal doxorubicin |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C455861 | pegfilgrastim |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D002955 | Leucovorin |
| D008727 | Methotrexate |
| D004317 | Doxorubicin |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D002330 | Carmustine |
| C078456 | denileukin diftitox |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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 |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000630 | Aminopterin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
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| Enteropathy-associated T-cell lymphoma |
|
| Subcutaneous panniculitis-like T-cell Lymphoma |
|
| Hepato-Splenic gamma-delta T-cell Lymphoma |
|
| Anaplastic large cell lymphoma, ALK- |
|
| Bone |
|
| Gastrointestinal |
|
| Lung |
|
| Liver |
|
| Thyroid |
|
| No extranodal site |
|
| Stage IV |
|
| Score of >=4 |
|
| Participants |
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| Participants |
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