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| ID | Type | Description | Link |
|---|---|---|---|
| UMN-0508M72589 | Other Identifier | IRB, University of Minnesota | |
| UMN-MT2004-24 | Other Identifier | Blood and Marrow Transplantation Program |
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RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF) alone: Patients not requiring further disease reduction receive G-CSF subcutaneously (SC) once daily on days 1-8. Patients undergo PBSC collection by leukapheresis on days 5-8. Patients who do not adequately mobilize with G-CSF alone proceed to chemo-mobilization.
Chemo-mobilization: Patients requiring further disease reduction receive 1 of 2 chemo-mobilization regimens.
Autologous PBSC transplantation (PBSCT) (Patients with NHL undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.
Autologous PBSCT (Patients with Hodgkin's lymphoma or NHL not undergoing irradiation and cyclophosphamide): Patients receive camustine IV over 2 hours on days -6, etoposide IV over 2 hours twice daily on days -5 to -2, and melphalan over 1 hour on day -1. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.
Autologous PBSC transplantation (PBSCT) (Patients with HL not undergoing irradiation): Patients receive cyclophosphamide IV over 2 hours on days -6 to -3, camustine IV over 2 hours on day -6, and etoposide IV over 4 hours twice daily on days -6 to -4. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.
Post-transplant irradiation: Patients undergo post-transplant irradiation beginning on day 28. Persisting nodal masses ≥ 2 cm are treated with additional localized external beam irradiation.
Post-transplant Rituximab therapy: patients with CD20+ NHL may undergo Rituximab maintenance starting between day +45 and +90 and being repeated at day +180 ± 14 days.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHL with irradiation | Experimental | Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. |
|
| HL without irradiation | Experimental | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. |
|
| NHL - HIV infected with irradiation | Experimental | Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. |
|
| NHL - HIV infected without irradiation | Experimental | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carmustine | Drug | Day -6, 300 mg/m^2 over 2 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 Year Progression Free Survival | Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy. | 1 year |
| Number of Participants With 2 Years Progression Free Survival | Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy. | 2 years |
| Number of Participants With 1 Year Overall Survival | 1 year | |
| Number of Participants With 2 Years Overall Survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hematopoietic Recovery After Transplantation | return to ANC (absolute neutrophil count) more than 500 cells/milliliter. | Day 42 |
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Inclusion Criteria:
Karnofsky performance status: >80% (>60% if poor performance status is related to lymphoma)
No evidence of serious organ dysfunction that is not attributable to tumor
Hepatitis B: Patients who are carriers of Hepatitis B will be included in this study. These patients are not eligible to receive rituximab as a component of their chemotherapy mobilization.
HIV disease. Patients with HIV disease are eligible for this study provided that:
Non-Hodgkin's lymphoma (NHL). Patients with chemo-sensitive histologically confirmed NHL.
Precursor B-cell or Precursor T-cell NHL
Lymphoblastic lymphoma
Mature B-cell Lymphomas:
Mature T-cell lymphoma
Hodgkin's lymphoma (HL)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronika Bachanova, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NHL With Irradiation | Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. |
| FG001 | HL Without Irradiation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2014 |
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| NHL without radiation and cyclosporine | Experimental | Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
|
|
| cyclophosphamide | Drug | NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing. |
|
|
| etoposide | Drug | NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4. |
|
|
| peripheral blood stem cell transplantation | Procedure | Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5. |
|
|
| irradiation therapy | Radiation | Patients undergo total body irradiation (TBI) twice daily on days -4 to -1.
|
|
| G-CSF | Biological | Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days. If ANC falls <1000/μL, restart G-CSF. |
|
|
| Cytarabine | Drug | 100 mg/m^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen. |
|
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Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
| FG002 | NHL - HIV Infected With Irradiation | Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. |
| FG003 | NHL - HIV Infected Without Irradiation | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. |
| FG004 | NHL Without Radiation and Cyclophosphamide | Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NHL With Irradiation | Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. |
| BG001 | HL Without Irradiation | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. |
| BG002 | NHL - HIV Infected With Irradiation | Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. |
| BG003 | NHL - HIV Infected Without Irradiation | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. |
| BG004 | NHL Without Radiation and Cyclophosphamide | Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
| BG005 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With 1 Year Progression Free Survival | Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy. | Posted | Count of Participants | Participants | 1 year |
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| |||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With 2 Years Progression Free Survival | Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy. | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With 1 Year Overall Survival | Posted | Count of Participants | Participants | 1 year |
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| Primary | Number of Participants With 2 Years Overall Survival | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematopoietic Recovery After Transplantation | return to ANC (absolute neutrophil count) more than 500 cells/milliliter. | Posted | Count of Participants | Participants | Day 42 |
|
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 | NHL With Irradiation | Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. | 47 | 171 | 34 | 171 | 125 | 171 |
| EG001 | HL Without Irradiation | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. | 9 | 149 | 18 | 149 | 98 | 149 |
| EG002 | NHL - HIV Infected With Irradiation | Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG003 | NHL - HIV Infected Without Irradiation | Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF. | 1 | 5 | 1 | 5 | 2 | 5 |
| EG004 | NHL Without Radiation and Cyclophosphamide | Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). | 25 | 146 | 0 | 146 | 120 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Relapse | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Myelodysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Death due to progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Death due to relapse | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Death due to multi organ failure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Decreased heart function | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Other Kidney disorder | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| sensory loss | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Intubation | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| GI bleeding | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| deconditioning | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Surgery | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| hypothyroidism | Endocrine disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Veronika Bachanova | Masonic Cancer Center, University of Minnesota | 612-625-5469 | bach0173@umn.edu |
| Jun 24, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D054685 | Lymphoma, Primary Effusion |
| 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 |
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| ID | Term |
|---|---|
| D002330 | Carmustine |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| 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 |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| 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 |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
| OG004 | NHL Without Radiation and Cyclophosphamide | Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
|
|
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
|
|
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
|
|
| OG004 | NHL Without Radiation and Cyclophosphamide | Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning). |
|
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