Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
Overview[ - collapse ][ - ]
| Purpose | The goal of this clinical research study is to compare chemotherapy given with rituximab to chemotherapy followed by rituximab. The safety of both treatment schedules will be studied. Laboratory tests of genetic changes in blood and bone marrow before and during the study will also be monitored. |
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| Condition | Lymphoma |
| Intervention | Drug: Fludarabine Drug: Novantrone Drug: Decadron Drug: Rituximab Drug: Interferon Drug: Doxorubicin Drug: Vincristine Drug: Bleomycin Drug: Cyclophosphamide Drug: Etoposide Drug: Cisplatin Drug: Ara-C Drug: Methyl-Prednisolone Drug: Procarbazine Drug: Prednisone |
| Phase | Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Responsible Party | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier | NCT00577993 |
| First Received | December 18, 2007 |
| Last Updated | September 5, 2013 |
| Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 18, 2007 |
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| Last Updated Date | September 5, 2013 |
| Start Date | March 1998 |
| Estimated Primary Completion Date | December 2014 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients |
|---|---|
| Official Title | Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma |
| Brief Summary | The goal of this clinical research study is to compare chemotherapy given with rituximab to chemotherapy followed by rituximab. The safety of both treatment schedules will be studied. Laboratory tests of genetic changes in blood and bone marrow before and during the study will also be monitored. |
| Detailed Description | Rituximab is a monoclonal antibody that is designed to attach to leukemia cells and activate a series of events that may cause the cancer cells to die. Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying. Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer. Study Groups: If you are found eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. Each group will receive 8 "cycles" of treatment. One (1) cycle will last 28 days. Group 1: If you are in Group 1, you will receive the following drugs at the following times. Each study cycle is 28 days: - Rituximab will be given through a needle in the vein over about 90 minutes on Days 1 and 8 of the first course Cycle 1, and on Day 1 only of Cycles 2-5 of Fludarabine/ Mitoxantrone/ Dexamethasone (FND) treatment. - Fludarabine will be given through a needle in the vein over about 15 minutes on Days 2-4 of each cycle. - Mitoxantrone will be given through a needle in the vein over about 15 minutes on Day 2 of each cycle. - You will take dexamethasone by mouth with water on Days 1-5 of each 28-day cycle (FND). If you miss any doses of the study drugs, please contact the research staff for instructions. You will not receive rituximab in Cycles 6-8. When the 8 cycles are finished, you will begin receiving the drug interferon on Days 1-14 each month for 1 year. Dexamethasone will be given on Days 1-3 every month for 1 year. Patients in group 2 will receive fludarabine on Days 1-3, mitoxantrone on Day 1, and dexamethasone on Days 1-5 of each 28-day cycle. When 8 cycles of treatment are finished, patients will begin receiving the drug interferon on Days 1-14 each month for 1 year. Dexamethasone will be given on Days 1-3 every month for 1 year. About 4 months after interferon treatment starts, patients in group 2 will begin receiving rituximab once a month for 6 months. Other drugs may be given to help decrease the risk of or ease side effects. Treatment may be delayed or stopped if side effects are severe. Most of the drugs are given by vein. A catheter (a tube) will be placed in a vein to decrease the number of needle sticks. Dexamethasone may be taken by mouth instead of given by vein. Some patients in this study, with changes in certain genes will receive different chemotherapy drugs than other patients in the study will. The patients will, like all the other patients, receive rituximab and interferon. But instead of the FND chemotherapy regimen, they will receive a sequence of three regimens, CHOD-Bleo, ESHAP, and NOPP. The drugs in these regimens include: cyclophosphamide, doxorubicin, vincristine, bleomycin, VP-16, Ara-C, cisplatin, mitoxantrone, procarbazine, and corticosteroids (prednisone, methylprednisolone, dexamethasone). During the study, patients will have blood tests every week. Complete exams will be given in Cycles 2 and 4; patients will return to the clinic for these. Every 2 or 3 cycles, patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow samples will be taken. Heart function tests (EKG) will be done as needed. After the study ends, patients will return for checkups every 3 months in the first year, every 4 months in years 2 and 3, and every 6 months in years 4 and 5. After that, checkups will be needed once a year. Blood and bone marrow samples will be taken at these visits. This is an investigational study. Rituximab is approved by FDA for commercial use. The other drugs used in the study are also approved for commercial use. About 210 patients will take part in the study. All will be enrolled at UTMDACC. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma |
| Intervention | Drug: Fludarabine Group 1= 25 mg/m^2 IV over 15 min. Days 2 through 4 for 8 Cycles; Group 2 = 25 mg/m^2 IV over 15 min. Days 1 through 3 for 8 Cycles. Other Names: 2-fluoro-Ara AmpDrug: Novantrone Group 1 = 10 mg/m^2 IV over 15 min. Day 2 for 8 Cycles; Group 2 = 10 mg/m^2 IV over 15 min. Day 1 for 8 Cycles; Group 3 = 10 mg/m^2 IV over 15 min. Day 2 of 3rd Sequence. Other Names: MitoxantroneDrug: Decadron Group 1 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 2 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 3 = 40 mg PO Days 1 through 4 of 1st Sequence; After Completion of 3 Sequences, Days 1 through 3 Every Month for 1 Year. Other Names: DexamethasoneDrug: Rituximab Group 1 = 375 mg/m^2 IV Days 1 through 8 of Course 1, then Day 1 Only of Cycles 2 through 5; Group 2 = 4 Months after IFN Starts, 375 mg/m^2 IV Once Per Month for 6 Months; Group 3 = 375 mg/m^2 IV Days 1 through 8 of 1st Sequence; 375 mg/m^2 IV Days 1 through 8 of 3rd Sequence. Other Names:
Group 1 = After Completion of Fludarabine, Novantrone, & Rituximab, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 2 = After Completion of Fludarabine & Novantrone, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 3 = After Completion of 3 Sequences, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year. Other Names:
25 mg/m^2 IV Days 2 & 3 of 1st Sequence. Drug: Vincristine .7 mg/m^2 IV Days 2 & 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence. Drug: Bleomycin 5 unit/m^2 IV Days 2 & 3 of 1st Sequence. Drug: Cyclophosphamide 750 mg/m^2 IV Day 2 of 1st Sequence. Drug: Etoposide 40 mg/m^2 IV Days 1 through 4 of 2nd Sequence. Drug: Cisplatin 25 mg/m^2 IV Days 1 through 4 of 2nd Sequence Drug: Ara-C 1.5 gm/m^2 IV Day 5 of 2nd Sequence. Drug: Methyl-Prednisolone 500 mg IV Days 1 through 5 of 2nd Sequence. Drug: Procarbazine 100 mg/m^2 PO Days 2 through 11 of 3rd Sequence. Drug: Prednisone 100 mg PO Days 1 through 5 of 3rd Sequence. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 210 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2014 |
| Eligibility Criteria | Inclusion Criteria: 1. Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001: eligibility restricted to follicular lymphoma] 2. Age <76 Exclusion Criteria: N/A |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00577993 |
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| Other Study ID Numbers | DM97-261 |
| Has Data Monitoring Committee | No |
| Information Provided By | M.D. Anderson Cancer Center |
| Study Sponsor | M.D. Anderson Cancer Center |
| Collaborators | Genentech |
| Investigators | Principal Investigator: Nathan Fowler, MD M.D. Anderson Cancer Center |
| Verification Date | September 2013 |
Locations[ + expand ][ + ]
| UT MD Anderson Cancer Center | Houston, Texas, United States, 77030 |
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