LymphomaPhase 3NCT00577993
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
A Phase 3 study testing Fludarabine, Novantrone and Decadron 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 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. Read more about this study
- Who is it for?
- Ages Up to 76 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Fludarabine, Novantrone and Decadron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 1998to 24 Aug 2017
- Phase
- Phase 3
- 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 Up to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001: eligibility restricted to follicular lymphoma]
- Age <76
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma
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.
Read the 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 University of Texas MD Anderson Cancer Center (UTMDACC).
- Conditions
- Lymphoma
- Being tested
- Fludarabine, Novantrone, Decadron, Rituximab, Interferon
- Keywords
- Lymphoma, Follicular Lymphoma, Indolent Lymphoma, Fludarabine, Novantrone, Mitoxantrone, Decadron, Dexamethasone, Rituximab, Anti-CD20, IDEC-C2B8, Chimeric Anti-CD20 Antibody, Interferon, Interferon Alpha-2b, IFN, Doxorubicin, Vincristine, Bleomycin, Cyclophosphamide, Etoposide
- Medical subject headings
- Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called 2-fluoro-Ara Amp
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.
NovantroneDrug
Also called Mitoxantrone
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.
DecadronDrug
Also called Dexamethasone
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.
RituximabDrug
Also called Chimeric Anti-CD20 Antibody, Anti-CD20, IDEC-C2B8
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.
InterferonDrug
Also called Interferon Alpha-2b, IFN
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.
DoxorubicinDrug
25 mg/m^2 IV Days 2 \& 3 of 1st Sequence.
VincristineDrug
.7 mg/m^2 IV Days 2 \& 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence.
BleomycinDrug
5 unit/m^2 IV Days 2 \& 3 of 1st Sequence.
CyclophosphamideDrug
750 mg/m^2 IV Day 2 of 1st Sequence.
EtoposideDrug
40 mg/m^2 IV Days 1 through 4 of 2nd Sequence.
CisplatinDrug
25 mg/m^2 IV Days 1 through 4 of 2nd Sequence
Ara-CDrug
1.5 gm/m^2 IV Day 5 of 2nd Sequence.
Methyl-PrednisoloneDrug
500 mg IV Days 1 through 5 of 2nd Sequence.
ProcarbazineDrug
100 mg/m^2 PO Days 2 through 11 of 3rd Sequence.
PrednisoneDrug
100 mg PO Days 1 through 5 of 3rd Sequence.
| Study group | Role | What they receive |
|---|---|---|
| 1: FND + Rituximab Followed by Interferon | Active comparator | Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon Receives: Drug: Fludarabine; Drug: Novantrone; Drug: Decadron; Drug: Rituximab; Drug: Interferon |
| 2: FND Followed by Interferon & Rituximab | Active comparator | Fludarabine/Novantrone/Decadron Followed by Interferon \& Rituximab Receives: Drug: Fludarabine; Drug: Novantrone; Drug: Decadron; Drug: Rituximab; Drug: Interferon |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Years
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study start16 Mar 1998
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Nathan Fowler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577993
- Sponsor's protocol ID
- DM97-261
- Other IDs
- NCI-2010-01566
- Status last verified
- Oct 2020
- First submitted
- 18 Dec 2007
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00577993
- Acronym / sponsor ID
- DM97-261
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Follicular Lymphoma, Indolent Lymphoma, Fludarabine, Novantrone, Mitoxantrone, Decadron, Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 16 Mar 1998 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Posted 16 Nov 2020
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 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 University of Texas MD Anderson Cancer Center (UTMDACC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: FND + Rituximab Followed by Interferon | Active comparator | Drug: Fludarabine, Drug: Novantrone, Drug: Decadron, Drug: Rituximab, Drug: InterferonFludarabine/Novantrone/Decadron + Rituximab Followed by Interferon |
| 2: FND Followed by Interferon & Rituximab | Active comparator | Drug: Fludarabine, Drug: Novantrone, Drug: Decadron, Drug: Rituximab, Drug: InterferonFludarabine/Novantrone/Decadron Followed by Interferon \& Rituximab |
| 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon | Active comparator | 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: PrednisoneCyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon |
Who may qualify
- Ages
- Up to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Previously untreated stage IV indolent B-cell lymphoma [Amendment May 2001: eligibility restricted to follicular lymphoma]
- Age <76
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| FludarabineAlso: 2-fluoro-Ara AmpGroup 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. | Drug | 1: FND + Rituximab Followed by Interferon, 2: FND Followed by Interferon & Rituximab |
| NovantroneAlso: MitoxantroneGroup 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. | Drug | 1: FND + Rituximab Followed by Interferon, 2: FND Followed by Interferon & Rituximab, 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| DecadronAlso: DexamethasoneGroup 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. | Drug | 1: FND + Rituximab Followed by Interferon, 2: FND Followed by Interferon & Rituximab, 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| RituximabAlso: Chimeric Anti-CD20 Antibody, Anti-CD20, IDEC-C2B8Group 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. | Drug | 1: FND + Rituximab Followed by Interferon, 2: FND Followed by Interferon & Rituximab, 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| InterferonAlso: Interferon Alpha-2b, IFNGroup 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. | Drug | 1: FND + Rituximab Followed by Interferon, 2: FND Followed by Interferon & Rituximab, 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Doxorubicin25 mg/m^2 IV Days 2 \& 3 of 1st Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Vincristine.7 mg/m^2 IV Days 2 \& 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Bleomycin5 unit/m^2 IV Days 2 \& 3 of 1st Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Cyclophosphamide750 mg/m^2 IV Day 2 of 1st Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Etoposide40 mg/m^2 IV Days 1 through 4 of 2nd Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Cisplatin25 mg/m^2 IV Days 1 through 4 of 2nd Sequence | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Ara-C1.5 gm/m^2 IV Day 5 of 2nd Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Methyl-Prednisolone500 mg IV Days 1 through 5 of 2nd Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Procarbazine100 mg/m^2 PO Days 2 through 11 of 3rd Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
| Prednisone100 mg PO Days 1 through 5 of 3rd Sequence. | Drug | 3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon |
Primary outcome
Number of Participants With Overall Survival (10 Years) by Treatment
Time frame: 10 Years
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.
1 secondary outcome
Number of Participants With Progression Free Survival (10 Years) by Treatment
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.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.
Nathan Fowler, 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 Phase 3 study testing Fludarabine, Novantrone and Decadron 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 2 inclusion and 1 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 16 Nov 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2020). 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?
Number of Participants With Overall Survival (10 Years) by Treatment (time frame: 10 Years). 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 16 Nov 2020.