LymphomaNCT00651755
Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
A study testing Aprepitant, Cyclophosphamide and Doxorubicin in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Aprepitant, Cyclophosphamide and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed or relapsed lymphoid malignancy.
- Patients receiving either:(1) Bolus or 48-hr infusion CHOP (cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given as bolus infusion or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days) OR (2) Bolus or 48-hr infusion R-CHOP (Rituximab 375mg/m^2 on Day 1+ CHOP as above). (For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician
- Age >/= to 18 years
- Adequate organ function defined as serum total bilirubin </= 1.2 mg/dL, serum aspartate aminotransferase or serum glutamate oxaloacetate transaminase (SGOT) </= 60 IU/L, creatinine < 1.5 mg/dL.
Who cannot join
- Evidence of neoplastic central nervous system disease
- Patients who are unable to take oral medication (e.g. due to tumor obstruction)
- History of Diabetes Mellitus (Diabetes as defined by established diagnosis of diabetes currently receiving medications for the diabetes management and/or a fasting blood glucose of >/= 126 mg/dL.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma
The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.
Read the detailed description
The Study Drugs:
Aprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by cancer chemotherapy treatment.
CHOP and R-CHOP are commonly used chemotherapy regimens for treating NHL.
In the blood, aprepitant may increase or decrease the drug levels of cyclophosphamide, vincristine, and/or prednisone (which are part of the CHOP and R-CHOP regimens), but this is not known for certain. This study is designed to help researchers learn the effect of combining aprepitant with CHOP and R-CHOP.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal chance of being assigned to either group.
Standard Chemotherapy Administration:
Both CHOP and R-CHOP typically have 21-day "cycles" but can vary from every 14 to 28 days. You will receive CHOP or R-CHOP according to the schedule prescribed by your doctor. You will also receive standard medications for preventing nausea and vomiting. You will sign a separate consent form that will describe these treatments in detail, along with their risks.
Aprepitant Administration:
Aprepitant is taken by mouth, with or without food.
Group 1 will take aprepitant on Days 1, 2, and 3 of Study Cycle 1 only. Group 2 will take aprepitant on Days 1, 2, and 3 of Study Cycle 2 only.
Study Diary:
Prior to each study cycle, you will be given a study diary to use throughout the study. Once a day, you will record any side effects you may have experienced. You should bring your study diary to every study visit so the study staff can review it.
Study Visits:
Prior to each study cycle, you will have a study visit with the following tests/procedures performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of vital signs and weight.
- You will have a performance status evaluation.
- You will fill out the same questionnaire you did at screening, about any nausea and vomiting you may be experiencing.
- You will be asked about any other medications you may be taking. Be sure to tell the study doctor about all medications (including vitamins, herbal products, and nutritional supplements), because some medications/substances will cause side effects when taken at the same time as aprepitant.
- The study staff will review your study diary.
Pharmacokinetic Testing:
You will have additional blood samples drawn for pharmacokinetic (PK) testing of cyclophosphamide, vincristine, and prednisone levels. PK testing measures the amount of the drug in the body at different time points. These PK blood draws will be about 2 tablespoons each.
On Days 1 and 2 of Study Cycles 1 and 2, blood will be drawn for PK testing at the following times: before taking prednisone, 30 minutes after the start of the cyclophosphamide infusion, and at 60 minutes, 75 minutes, 90 minutes, and 2, 4, 6, 8, and 24 hours after the start of the cyclophosphamide infusion.
Other Blood Tests:
At least twice a week during Study Cycles 1 and 2, blood (about 1 teaspoon) will be drawn for routine tests.
Aprepitant may increase the blood sugar during the first few days the drug is taken. Because of this, on Day 1 of Study Cycle 1, you will be given a glucometer (a machine to check your blood sugar). You will use the glucometer at home during the study (or in the hospital if you are admitted there for chemotherapy). You will be given instructions on how to use it, and what to be looking for. On Days 1-6 of Study Cycle 1, you will give yourself a "fingerstick" blood sugar test once a day (before breakfast). You will take a "fingerstick" blood sugar test before you receive each dose of aprepitant.
Length of Study:
You may receive up to 2 cycles of chemotherapy, including 1 cycle of aprepitant. If intolerable side effects occur or the disease gets worse, you will be taken off study early.
End-of-Study Visit:
At 30 days after your last dose of aprepitant, you will return for an end-of-study visit. At this visit, you will have the same tests/procedures performed that you did at the other study visits. You will return the glucometer to the study staff.
This is an investigational study. The CHOP and R-CHOP regimens are commercially available and FDA approved for use in NHL.
Aprepitant is commercially available and FDA approved (when used in combination with other nausea medication, such as ondansetron) for the prevention of nausea and vomiting that may be caused by chemotherapy. However, this study is considered experimental because researchers want to find out how aprepitant may affect the drug levels of cyclophosphamide, vincristine, and prednisone in the blood. (Cyclophosphamide, vincristine, and prednisone are part of the CHOP and R-CHOP regimens.) The use of aprepitant is authorized for this experimental purpose.
Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lymphoma
- Being tested
- Aprepitant, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Nausea, Cyclophosphamide, Cytoxan, Neosar, Doxorubicin, AD, Hydroxydaunomycin hydrochloride, Vincristine, Prednisone, Rituximab, Rituxan, Aprepitant, Emend, L754030, MK869, Drug Metabolism, CHOP, R-CHOP
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend, L754030, MK869
125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3.
CyclophosphamideDrug
Also called Cytoxan, Neosar
750 mg/m^2 By Vein On Day 1
DoxorubicinDrug
Also called AD, Hydroxydaunomycin hydrochloride
25 mg/m^2 By Vein Over 48 Hours On Days 1-2
VincristineDrug
2 mg By Vein On Day 1
PrednisoneDrug
100 mg PO for 5 Days
RituximabDrug
Also called Rituxan
375 mg/m^2 By Vein On Day 1.
OndansetronDrug
8 mg daily for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant + CHOP/R-CHOP | Experimental | Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]. [For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician] Receives: Drug: Aprepitant; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab |
| Standard of Care (Control) + CHOP/R-CHOP | Experimental | Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Measured: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Measured: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Measured: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Measured: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Measured: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Measured: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651755
- Sponsor's protocol ID
- 2006-1033
- Status last verified
- Jun 2013
- First submitted
- 31 Mar 2008
- Last updated
- 2 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00651755
- Acronym / sponsor ID
- 2006-1033
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Nausea, Cyclophosphamide, Cytoxan, Neosar, Doxorubicin, AD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.
Detailed description
The Study Drugs:
Aprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by cancer chemotherapy treatment.
CHOP and R-CHOP are commonly used chemotherapy regimens for treating NHL.
In the blood, aprepitant may increase or decrease the drug levels of cyclophosphamide, vincristine, and/or prednisone (which are part of the CHOP and R-CHOP regimens), but this is not known for certain. This study is designed to help researchers learn the effect of combining aprepitant with CHOP and R-CHOP.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal chance of being assigned to either group.
Standard Chemotherapy Administration:
Both CHOP and R-CHOP typically have 21-day "cycles" but can vary from every 14 to 28 days. You will receive CHOP or R-CHOP according to the schedule prescribed by your doctor. You will also receive standard medications for preventing nausea and vomiting. You will sign a separate consent form that will describe these treatments in detail, along with their risks.
Aprepitant Administration:
Aprepitant is taken by mouth, with or without food.
Group 1 will take aprepitant on Days 1, 2, and 3 of Study Cycle 1 only. Group 2 will take aprepitant on Days 1, 2, and 3 of Study Cycle 2 only.
Study Diary:
Prior to each study cycle, you will be given a study diary to use throughout the study. Once a day, you will record any side effects you may have experienced. You should bring your study diary to every study visit so the study staff can review it.
Study Visits:
Prior to each study cycle, you will have a study visit with the following tests/procedures performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of vital signs and weight.
- You will have a performance status evaluation.
- You will fill out the same questionnaire you did at screening, about any nausea and vomiting you may be experiencing.
- You will be asked about any other medications you may be taking. Be sure to tell the study doctor about all medications (including vitamins, herbal products, and nutritional supplements), because some medications/substances will cause side effects when taken at the same time as aprepitant.
- The study staff will review your study diary.
Pharmacokinetic Testing:
You will have additional blood samples drawn for pharmacokinetic (PK) testing of cyclophosphamide, vincristine, and prednisone levels. PK testing measures the amount of the drug in the body at different time points. These PK blood draws will be about 2 tablespoons each.
On Days 1 and 2 of Study Cycles 1 and 2, blood will be drawn for PK testing at the following times: before taking prednisone, 30 minutes after the start of the cyclophosphamide infusion, and at 60 minutes, 75 minutes, 90 minutes, and 2, 4, 6, 8, and 24 hours after the start of the cyclophosphamide infusion.
Other Blood Tests:
At least twice a week during Study Cycles 1 and 2, blood (about 1 teaspoon) will be drawn for routine tests.
Aprepitant may increase the blood sugar during the first few days the drug is taken. Because of this, on Day 1 of Study Cycle 1, you will be given a glucometer (a machine to check your blood sugar). You will use the glucometer at home during the study (or in the hospital if you are admitted there for chemotherapy). You will be given instructions on how to use it, and what to be looking for. On Days 1-6 of Study Cycle 1, you will give yourself a "fingerstick" blood sugar test once a day (before breakfast). You will take a "fingerstick" blood sugar test before you receive each dose of aprepitant.
Length of Study:
You may receive up to 2 cycles of chemotherapy, including 1 cycle of aprepitant. If intolerable side effects occur or the disease gets worse, you will be taken off study early.
End-of-Study Visit:
At 30 days after your last dose of aprepitant, you will return for an end-of-study visit. At this visit, you will have the same tests/procedures performed that you did at the other study visits. You will return the glucometer to the study staff.
This is an investigational study. The CHOP and R-CHOP regimens are commercially available and FDA approved for use in NHL.
Aprepitant is commercially available and FDA approved (when used in combination with other nausea medication, such as ondansetron) for the prevention of nausea and vomiting that may be caused by chemotherapy. However, this study is considered experimental because researchers want to find out how aprepitant may affect the drug levels of cyclophosphamide, vincristine, and prednisone in the blood. (Cyclophosphamide, vincristine, and prednisone are part of the CHOP and R-CHOP regimens.) The use of aprepitant is authorized for this experimental purpose.
Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant + CHOP/R-CHOP | Experimental | Drug: Aprepitant, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: RituximabAprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]. [For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician] |
| Standard of Care (Control) + CHOP/R-CHOP | Experimental | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Rituximab, Drug: OndansetronAnti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed or relapsed lymphoid malignancy.
- Patients receiving either:(1) Bolus or 48-hr infusion CHOP (cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given as bolus infusion or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days) OR (2) Bolus or 48-hr infusion R-CHOP (Rituximab 375mg/m^2 on Day 1+ CHOP as above). (For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician
- Age >/= to 18 years
- Adequate organ function defined as serum total bilirubin </= 1.2 mg/dL, serum aspartate aminotransferase or serum glutamate oxaloacetate transaminase (SGOT) </= 60 IU/L, creatinine < 1.5 mg/dL.
Key exclusion criteria (3 listed)
- Evidence of neoplastic central nervous system disease
- Patients who are unable to take oral medication (e.g. due to tumor obstruction)
- History of Diabetes Mellitus (Diabetes as defined by established diagnosis of diabetes currently receiving medications for the diabetes management and/or a fasting blood glucose of >/= 126 mg/dL.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantAlso: Emend, L754030, MK869125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3. | Drug | Aprepitant + CHOP/R-CHOP |
| CyclophosphamideAlso: Cytoxan, Neosar750 mg/m^2 By Vein On Day 1 | Drug | Aprepitant + CHOP/R-CHOP, Standard of Care (Control) + CHOP/R-CHOP |
| DoxorubicinAlso: AD, Hydroxydaunomycin hydrochloride25 mg/m^2 By Vein Over 48 Hours On Days 1-2 | Drug | Aprepitant + CHOP/R-CHOP, Standard of Care (Control) + CHOP/R-CHOP |
| Vincristine2 mg By Vein On Day 1 | Drug | Aprepitant + CHOP/R-CHOP, Standard of Care (Control) + CHOP/R-CHOP |
| Prednisone100 mg PO for 5 Days | Drug | Aprepitant + CHOP/R-CHOP, Standard of Care (Control) + CHOP/R-CHOP |
| RituximabAlso: Rituxan375 mg/m^2 By Vein On Day 1. | Drug | Aprepitant + CHOP/R-CHOP, Standard of Care (Control) + CHOP/R-CHOP |
| Ondansetron8 mg daily for 2 days | Drug | Standard of Care (Control) + CHOP/R-CHOP |
Primary outcome
Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
Time frame: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
Time frame: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
Time frame: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
Time frame: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
Time frame: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
Time frame: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during \& post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant, Cyclophosphamide and Doxorubicin in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group (time frame: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.