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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00131 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 72806 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare 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.
PRIMARY OBJECTIVES:
I. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen.
SECONDARY OBJECTIVES:
I. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen.
II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT).
OUTLINE:
Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen CBV (patients with HL or NHL) | Experimental | Patients receive etoposide intravenously (IV) continuously over 34 hours on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3. Patients undergo ASCT on day 0. |
|
| Regimen M200/M120 (patients with MM or amyloidosis) | Experimental | Patients receive 200 or 120 mg/m^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0. |
|
| Regimen BuC2iv (patients with ALL, AML, HL, or NHL) | Experimental | Patients receive busulfan IV over 2 hours then every 6 hours on days -7 to -4 for 16 total doses and cyclophosphamide IV over 2 hours on days -3 and -2. Patients undergo ASCT on day 0. |
|
| Regimen CT6 (patients with ALL) | Experimental | Patients receive cyclophosphamide IV over 2 hours on days -5 to -4. Patients then undergo TBI twice daily on days -3 to -1. Patients undergo ASCT on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoposide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. | From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years |
| Measure | Description | Time Frame |
|---|---|---|
| Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) | Toxicities will be reported using descriptive statistics. | Up to 100 days after transplantation |
| Response Rate (Complete Remission) |
Not provided
Inclusion Criteria:
Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy
Recurrent or refractory disease or disease at high risk for recurrence
Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen
Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score
Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits
Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits
Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression
Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy
Amyloidosis: primary or previously treated
Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient
Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible
Life expectancy > 2 months
Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation
Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or echocardiogram
Bilirubin < 3 x normal
Alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) < 3 x normal
Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics
Glomerular filtration rate by renal scan for neuroblastoma patients, to determine dosing parameters
Positive cytomegalovirus (CMV) immunoglobulin M (IgM) and/or positive hepatitis serologies demonstrating infection will require an Infectious Disease consult and subsequent clearance
Any active infection will require an Infectious Disease consult and subsequent clearance
Peripheral Blood Counts of polymorphonuclear neutrophil (PMN) > 1500/uL
Platelet (Plt) > 75,000/uL
Prior to stem cell storage:
Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but on appropriate anti-retroviral therapy may go autotransplant with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number < 100,000 per microliter and with Infectious Disease clearance
Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells; small round blue cell tumor patients must have received either standard therapy or surgical intervention; the disease status and response to therapy must be known prior to transplant to establish the disease status at transplant; amyloidosis patients may proceed to BMT without receiving chemotherapy
No serious organ dysfunction unless it is caused by the underlying disease, exclusion criteria include the following:
No serious medical or psychiatric illness
Not pregnant
No psychiatric conditions which would prevent delivery of care; psychology clearance is necessary
Allogeneic BMT not possible, or not desirable
Adequate bone marrow or blood stem cell dose obtained:
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| Name | Affiliation | Role |
|---|---|---|
| Philip McCarthy | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Leukemia | Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia |
| FG001 | Hodgkin Lymphoma | Patients diagnosed with and treated for Hodgkin Lymphoma |
| 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 | Feb 6, 2018 |
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| Regimen CTtCp (patients with other solid tumors) | Experimental | Patients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously over 24 hours on days -7 to -4. Patients undergo ASCT on day 0. |
|
| Regimen VCp (patients with testicular cancer) | Experimental | Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients then undergo a second ASCT on day 0. |
|
| Regimen TtC1500/ECpM (patients with NBL or SRBCT) | Experimental | Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 2 hours on days -5 to -2. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive carboplatin IV continuously over 24 hours on days -7 to -4, etoposide IV continuously over 24 hours on days -7 to -4, and melphalan IV over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0. |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| carmustine | Drug | Given IV |
|
|
| melphalan | Drug | Given IV |
|
|
| busulfan | Drug | Given IV |
|
|
| carboplatin | Drug | Given IV |
|
|
| thiotepa | Drug | Given IV |
|
|
| total-body irradiation | Radiation | Undergo TBI |
|
|
| autologous hematopoietic stem cell transplantation | Procedure | Undergo ASCT |
|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | Undergo tandem ASCT |
|
Response rates will be reported using descriptive statistics.
| At 100 days |
| Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) | Assessed using the product-limit based Kaplan Meier method. | Patients are followed up to maximum of 12 years |
| FG002 | Non-Hodgkin Lymphoma | Patients diagnosed with and treated for Non-Hodgkin Lymphoma |
| FG003 | MM/Amyloid | Patients diagnosed with or treated for multiple myeloma or amyloidosis |
| FG004 | Solid Tumors | Patients diagnosed with and treated for a solid tumor |
| COMPLETED |
|
| NOT COMPLETED |
|
Patients enrolled on study and stratified by disease group as defined in statistical analysis section of protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Leukemia | Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia |
| BG001 | Hodgkin Lymphoma | Patients diagnosed with and treated for Hodgkin Lymphoma |
| BG002 | Non-Hodgkin Lymphoma | Patients diagnosed with and treated for Non-Hodgkin Lymphoma |
| BG003 | MM/Amyloid | Patients diagnosed with or treated for multiple myeloma or amyloidosis |
| BG004 | Solid Tumors | Patients diagnosed with and treated for a solid tumor |
| 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Risk Group | 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 | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. | Each disease strata presents PFS for each conditioning regimen defined in the protocol | Posted | Number | 95% Confidence Interval | Proportion of participants | From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) | Toxicities will be reported using descriptive statistics. | Posted | Count of Participants | Participants | Up to 100 days after transplantation |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate (Complete Remission) | Response rates will be reported using descriptive statistics. | Posted | Count of Participants | Participants | At 100 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) | Assessed using the product-limit based Kaplan Meier method. | Posted | Number | 95% Confidence Interval | Proportion of participants | Patients are followed up to maximum of 12 years |
|
SAE= 100 days after transplantation All cause mortality = 12 years
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
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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 | Acute Leukemia | Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia | 4 | 6 | 1 | 6 | 0 | 6 |
| EG001 | Hodgkin Lymphoma | Patients diagnosed with and treated for Hodgkin Lymphoma | 8 | 21 | 9 | 21 | 0 | 21 |
| EG002 | Non-Hodgkin Lymphoma | Patients diagnosed with and treated for Non-Hodgkin Lymphoma | 41 | 71 | 19 | 71 | 0 | 71 |
| EG003 | MM/Amyloid | Patients diagnosed with or treated for multiple myeloma or amyloidosis | 45 | 65 | 31 | 65 | 0 | 65 |
| EG004 | Solid Tumors | Patients diagnosed with and treated for a solid tumor | 6 | 11 | 3 | 11 | 0 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Regimen Related Toxicity | General disorders | Bearman Criteria | Systematic Assessment | Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Hahn, PhD | Roswell Park Cancer Institute | 716-845-5819 | theresa.hahn@roswellpark.org |
| Mar 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D064090 | Intraocular Lymphoma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D054219 | Neoplasms, Plasma Cell |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D013736 | Testicular Neoplasms |
| D020522 | Lymphoma, Mantle-Cell |
| D009447 | Neuroblastoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010265 | Paraproteinemias |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D007951 | Leukemia, Myeloid |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D004701 | Endocrine Gland Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D003520 | Cyclophosphamide |
| D002330 | Carmustine |
| D008558 | Melphalan |
| D002066 | Busulfan |
| D016190 | Carboplatin |
| D013852 | Thiotepa |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D056831 | Coordination Complexes |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| 40-59 years |
|
| 60-75 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Standard |
|
| Unknown |
|
|
| CBV |
|
|
| VCp |
|
|
| Mel120 |
|
|
| Mel200 |
|
|
| CyTtCp |
|
|
| TtC1500 |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|