An interventional study of etoposide and cyclophosphamide in Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Treatment
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.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
This study's enrollment of 174 is above the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Compared within Lymphoma, Extranodal NK-T-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
Prior to stem cell storage:
No serious organ dysfunction unless it is caused by the underlying disease, exclusion criteria include the following:
Allogeneic BMT not possible, or not desirable
Adequate bone marrow or blood stem cell dose obtained:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: etoposide · Drug: cyclophosphamide · Drug: carmustine · Procedure: autologous hematopoietic stem cell transplantation
Patients receive 200 or 120 mg/m\^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.
Drug: melphalan · Procedure: autologous hematopoietic stem cell transplantation
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.
Drug: cyclophosphamide · Drug: busulfan · Procedure: autologous hematopoietic stem cell transplantation
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.
Drug: cyclophosphamide · Radiation: total-body irradiation · Procedure: autologous hematopoietic stem cell transplantation
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.
Drug: cyclophosphamide · Drug: carboplatin · Drug: thiotepa · Procedure: autologous hematopoietic stem cell transplantation
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.
Drug: etoposide · Drug: carboplatin · Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
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.
Drug: etoposide · Drug: cyclophosphamide · Drug: melphalan · Drug: carboplatin · Drug: thiotepa · Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Given IV
Also known as: EPEG, VP-16, VP-16-213
Given IV
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given IV
Also known as: BCNU, BiCNU, bis-chloronitrosourea
Given IV
Also known as: Alkeran, CB-3025, L-PAM, L-phenylalanine mustard, L-Sarcolysin
Given IV
Also known as: BSF, BU, Misulfan, Mitosan, Myeloleukon
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: Oncotiotepa, STEPA, TESPA, Tespamin, TSPA
Undergo TBI
Also known as: TBI
Undergo ASCT
Undergo tandem ASCT
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.
Time frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years
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.
Time frame: Up to 100 days after transplantation
Response Rate (Complete Remission)
Response rates will be reported using descriptive statistics.
Time frame: 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.
Time frame: Patients are followed up to maximum of 12 years
| Milestone | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors |
|---|---|---|---|---|---|
| Started | 6 | 21 | 71 | 65 | 11 |
| Completed | 6 | 21 | 71 | 65 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
| Proportion of participants | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors |
|---|---|---|---|---|---|
| BuCy | 33 (0 to 71) | 14 (0 to 40) | 22 (7 to 38) | — | — |
| CBV | — | 43 (17 to 69) | 37 (23 to 52) | — | — |
| VCp | — | — | 0 (0 to 0) | — | 43 (6 to 80) |
| Mel120 | — | — | — | 22 (2 to 41) | — |
| Mel200 | — | — | — | 13 (3 to 22) | — |
| CyTtCp | — | — | — | — | 0 (0 to 0) |
| TtC1500 | — | — | — | — | 50 (0 to 100) |
Toxicities will be reported using descriptive statistics.
| Participants | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors |
|---|---|---|---|---|---|
| Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) | 1 | 9 | 19 | 31 | 3 |
Response rates will be reported using descriptive statistics.
| Participants | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors |
|---|---|---|---|---|---|
| Response Rate (Complete Remission) | 5 | 17 | 54 | 17 | 7 |
Assessed using the product-limit based Kaplan Meier method.
| Proportion of participants | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors |
|---|---|---|---|---|---|
| Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) | 33 (0 to 71) | 61 (40 to 82) | 45 (33 to 57) | 39 (27 to 51) | 46 (16 to 75) |
Collected over SAE= 100 days after transplantation All cause mortality = 12 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acute Leukemia | 4/6 (66.7%) | 1/6 (16.7%) | 0/6 (0%) |
| Hodgkin Lymphoma | 8/21 (38.1%) | 9/21 (42.9%) | 0/21 (0%) |
| Non-Hodgkin Lymphoma | 41/71 (57.7%) | 19/71 (26.8%) | 0/71 (0%) |
| MM/Amyloid | 45/65 (69.2%) | 31/65 (47.7%) | 0/65 (0%) |
| Solid Tumors | 6/11 (54.5%) | 3/11 (27.3%) | 0/11 (0%) |
| Event | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors |
|---|---|---|---|---|---|
| Regimen Related ToxicityGeneral disorders | 1/6 | 9/21 | 19/71 | 31/65 | 3/11 |
Patients enrolled on study and stratified by disease group as defined in statistical analysis section of protocol
| Age, Customized(Participants) | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors | Total |
|---|---|---|---|---|---|---|
| 0-39 years | 1 | 8 | 6 | 3 | 9 | 27 |
| 40-59 years | 1 | 7 | 43 | 26 | 2 | 79 |
| 60-75 years | 4 | 6 | 22 | 36 | 0 | 68 |
| Sex: Female, Male(Participants) | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors | Total |
|---|---|---|---|---|---|---|
| Female | 5 | 11 | 23 | 29 | 3 | 71 |
| Male | 1 | 10 | 48 | 36 | 8 | 103 |
| Ethnicity (NIH/OMB)(Participants) | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 0 | 0 | 2 |
| Not Hispanic or Latino | 6 | 20 | 70 | 65 | 11 | 172 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 | 8 | 1 | 15 |
| White | 4 | 20 | 68 | 57 | 10 | 159 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors | Total |
|---|---|---|---|---|---|---|
| United States | 6 | 21 | 71 | 65 | 11 | 174 |
| Risk Group(Participants) | Acute Leukemia | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | MM/Amyloid | Solid Tumors | Total |
|---|---|---|---|---|---|---|
| High | 6 | 10 | 43 | 10 | 11 | 80 |
| Standard | 0 | 11 | 24 | 44 | 0 | 79 |
| Unknown | 0 | 0 | 4 | 11 | 0 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Etoposide · Cyclophosphamide · Carmustine · Melphalan · Busulfan · Carboplatin · Thiotepa
Lymphoma, Extranodal NK-T-Cell →
Roswell Park Cancer Institute →