Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01566 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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:
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 University of Texas MD Anderson Cancer Center (UTMDACC).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: FND + Rituximab Followed by Interferon | Active Comparator | Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon |
|
| 2: FND Followed by Interferon & Rituximab | Active Comparator | Fludarabine/Novantrone/Decadron Followed by Interferon & Rituximab |
|
| 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon | Active Comparator | Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Survival (10 Years) by Treatment | Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression Free Survival (10 Years) by Treatment | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 10 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
N/A
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathan Fowler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
Not provided
35 participants without Bcl Gene rearrangement were not randomized to the study
Recruitment period: March 1998 to May 2002
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex |
| FG001 | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 22, 2001 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Novantrone | Drug | 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. |
|
|
| Decadron | Drug | 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. |
|
|
| Rituximab | Drug | 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. |
|
|
| Interferon | Drug | 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. |
|
|
| Doxorubicin | Drug | 25 mg/m^2 IV Days 2 & 3 of 1st Sequence. |
|
| Vincristine | Drug | .7 mg/m^2 IV Days 2 & 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence. |
|
| Bleomycin | Drug | 5 unit/m^2 IV Days 2 & 3 of 1st Sequence. |
|
| Cyclophosphamide | Drug | 750 mg/m^2 IV Day 2 of 1st Sequence. |
|
| Etoposide | Drug | 40 mg/m^2 IV Days 1 through 4 of 2nd Sequence. |
|
| Cisplatin | Drug | 25 mg/m^2 IV Days 1 through 4 of 2nd Sequence |
|
| Ara-C | Drug | 1.5 gm/m^2 IV Day 5 of 2nd Sequence. |
|
| Methyl-Prednisolone | Drug | 500 mg IV Days 1 through 5 of 2nd Sequence. |
|
| Procarbazine | Drug | 100 mg/m^2 PO Days 2 through 11 of 3rd Sequence. |
|
| Prednisone | Drug | 100 mg PO Days 1 through 5 of 3rd Sequence. |
|
Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.
| FG002 | Patients Without Bcl Gene Rearrangement | ATT9 cycles; Rituximab 6 cycles |
| COMPLETED |
|
| NOT COMPLETED |
|
|
No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex |
| BG001 | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex. |
| BG002 | Patients w/o Bcl Gene Rearrangement | ATT 9 cycles; Rituximab 6 cycles |
| BG003 | 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, Continuous | Mean | Full Range | years |
| ||||||||||
| 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 |
| |||||||||||
| Indolent Lymphoma Subtype | Indolent lymphomas characterized by slow-growing B-cell malignancies: Small lymphocyte (SLL), Malignant Zone (MZL), & Follicular Lymphoma (FL). | No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype | Number | 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 | Number of Participants With Overall Survival (10 Years) by Treatment | Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. | The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Posted | Count of Participants | Participants | 10 Years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression Free Survival (10 Years) by Treatment | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Posted | Count of Participants | Participants | 10 years |
|
|
10 years
Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex | 19 | 78 | 67 | 78 | 67 | 78 |
| EG001 | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex. | 22 | 80 | 77 | 80 | 77 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Neutropenic Fever | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Nausea/Emesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Neutropenic Fever | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Nausea / Emisis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Rash / Pruitius | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathan Fowler,MD, Clinical Professor, Lymphoma-Myeloma | UT MD Anderson Cancer Center | (832) 671-3018 | nfowler@mdanderson.org |
| Oct 16, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| D008942 | Mitoxantrone |
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| D000069283 | Rituximab |
| D007372 | Interferons |
| D007438 | Introns |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D001761 | Bleomycin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| D003561 | Cytarabine |
| D011344 | Procarbazine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D011244 | Pregnadienediols |
Not provided
Not provided
|
|
|
|
|
| United Arab Emirates |
|
|
| China |
|
|
| Panama |
|
|
| Malta |
|
|
| Mexico |
|
|
|
| MZL |
|
|
| SLL |
|
|
|