Viewing Study NCT00290498



Ignite Creation Date: 2024-05-05 @ 4:41 PM
Last Modification Date: 2024-10-26 @ 9:22 AM
Study NCT ID: NCT00290498
Status: COMPLETED
Last Update Posted: 2020-06-02
First Post: 2006-02-10

Brief Title: Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkins Lymphomas in Patients 60 Years Old or Younger
Sponsor: MD Anderson Cancer Center
Organization: MD Anderson Cancer Center

Study Overview

Official Title: A Phase II Randomized Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkins Lymphomas in Patients 60 Years Old or Younger
Status: COMPLETED
Status Verified Date: 2020-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The overall goal of this clinical research study was to find out which of two different chemotherapy drug combinations R-CHOP and R-HCVAD is more effective in treating B-cell lymphoma

At this point all participants will now be assigned to the R-HCVAD arm of the study Researchers will study the safety and effectiveness of this drug combination
Detailed Description: This study originally involved 2 different study drug regimens R-CHOP and R-HCVAD R-CHOP is made up of rituximab cyclophosphamide vincristine and prednisone and is the most common treatment for patients with non-Hodgkins lymphoma This combination was compared with R-HCVAD which is made up of rituximab doxorubicin cyclophosphamide vincristine and dexamethasone

Rituximab Rituxan is a humanized monoclonal antibody against cluster of differentiation antigen 20 CD20 a receptor in the surface of malignant B-cell lymphocytes The drug has activity against aggressive and nonaggressive NHL of B-cell origin and has been used in combination with chemotherapy Cyclophosphamide is a type of drug know as an alkylating agent Vincristine is a type of drug called vinca alkaloids It is typically used in lymphomas leukemias and other tumors Prednisone is a type of steroid Dexamethasone is a steroid that may have activity against lymphomas Methotrexate is an anti-cancer drug and a folic acid antagonist It is used to treat solid tumors lymphomas leukemias and autoimmune diseases

When this study began participants were randomly assigned as in the flip of a coin to 1 of 2 arms Arm A R-HCVAD alternating with a combination of rituximab methotrexate and Ara-C or Arm B R-CHOP From this point on all new participants will be treated with the Arm A combination which has shown to be better

If you are found to be eligible to take part in this study you will be given the study drugs in 21-day cycles The cycles will alternate between R-HCVAD and a combination of rituximab methotrexate and Ara-C During Cycle 1 the R-HCVAD cycle you will receive rituximab through a needle in your vein intravenously or IV on Day 1 The infusion will take about 1 hour Cyclophosphamide will be given by IV every 12 hours for 3 days Each infusion of cyclophosphamide will take about 3 hours Doxorubicin will be given as a 15-minute infusion on Day 5 with the supervision of a nurse Your doctor may also choose to give you the doxorubicin over 24-48 hours using a small pump that you will carry around your waist in a fanny pack You will not have to stay in the hospital to receive this study drug Vincristine will be given by IV on Days 5 and 12 Each vincristine infusion will take about an hour Dexamethasone will be given by mouth as a pill capsule or tablet on Days 2-5 and 12-15 You will also be given other standard medications to help prevent possible side effects of these medications such as nausea vomiting or rash

In Cycle 2 the rituximab-methotrexate-Ara-C cycle you will receive rituximab on Day 1 You will receive methotrexate by IV after finishing the rituximab on Days 2 and 3 The infusion will take about 24 hours You will be given a small fanny pack with a pump inside that will slowly infuse the drug You do not have to stay in the hospital while the drug is being given You will be given Ara-C every 12 hours on Days 3-4 a total of 4 doses You will be given other standard medications to help prevent possible side effects of these medications such as nausea vomiting or rash during this cycle also

Leucovorin is given 12 hours after each methotrexate infusion It is used to stop the action of the methotrexate and to preventlessen any side effects that the methotrexate may cause

During treatment you will have blood draws between 2-3 tablespoons every week for routine tests Every 4 weeks during treatment you will be asked questions about your medical history and have a physical exam to check for any side effects Every 2 cycles about every 8 weeks you will have bone marrow biopsies performed if they were positive before starting on this study until they come back negative You will have a positron emission tomography PET scan to see if the tumor is responding Once the PET scan comes back negative it will be up to your physician to decide if you need additional PET scan tests and when You will have CT scans of the chest abdomen pelvis and neck every 2 cycles if they were positive at the beginning of the study also You may have additional testing done while on this study if your physician feels that it is needed for example if it is needed to check for side effects

You may receive additional medication called CNS prophylaxis before receiving the study treatments Your doctor will discuss these medications with you The CNS prophylaxis consists of an alternating dose of either doxorubicin or methotrexate The methotrexate will be given either by IV pump or by a lumbar puncture a needle inserted into the space between the vertebrae in your back to infuse the drug directly into the spinal area The doxorubicin will be given by IV Changes in the dose level of CNS prophylaxis will be approved if you are at risk for or are experiencing serious side effects

You will receive the study drugs for up to 6-8 cycles on an outpatient basis This means you will not have to be admitted to the hospital to receive the study drugs You may be taken off study if the disease gets worse If you experience intolerable side effects while taking any of the study drugs your study doctor may decide to delay your treatment for up to 3 weeks one study cycle or to continue your therapy on the drugs at a lower dose If the side effects become very severe your doctor may decide to take you off of the study and stop the medication

At the end of your scheduled treatments you will be asked to return to the clinic for follow-up visits every 6 months for the first second third and fourth year after treatment on this study You will then be followed every year after that If your doctor feels it is necessary you may have blood tests about 3-5 teaspoons performed at these visits You will have bone marrow biopsies every other year for the first 2 years if they were positive before you started on this study and then every year after that At these visits you will be asked about any side effects you may have experienced and whether or not your cancer has come back If your doctor feels there is a chance that the cancer has come back he or she may schedule x-rays or scans in order to check You will also be asked about any other therapies you may be having to treat your cancer if it has come back

If you are taken off study for any reason you will be asked to come back to the clinic for an end-of-treatment visit within 4 weeks from the last treatment This visit will include a physical exam routine blood tests about 5-8 teaspoons a blood-pregnancy test for women who are able to get pregnant an ECG and a chest x-ray

This is an investigational study All of the study drugs are approved by the FDA for the treatment of lymphoma Up to 66 patients will take part in this study All of the patients will be enrolled at MD Anderson

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-2012-01355 REGISTRY NCI CTRP None