A Phase 2 interventional study of rituximab and Cyclophosphamide in Lymphoma, sponsored by SWOG Cancer Research Network. Completed at 48 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 15 months.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 46 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
Stage I, IE, or non-bulky* stage II or IIE disease by Ann Arbor classification
Aggressive lymphomas must have at least 1 of the following adverse prognostic factors:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Biological: rituximab · Drug: Cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: prednisone · Drug: vincristine sulfate · Radiation: radiation therapy · Biological: Yttrium-90 ibritumomab tiuxetan · Biological: Indium-111 ibritumomab tiuxetan
250 mg/m\^2, as part of Zevalin regimen
750 mg/m\^2
50 mg/m\^2
100 mg
1.4 mg/m\^2
4000-5000 cGy total
0.4 mCi/kg
5 mCi
Progression-free Survival
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time frame: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter
| Milestone | CHOP + RT + Zevalin |
|---|---|
| Started | 46 |
| Eligible | 46 |
| Eligible and began protocol therapy | 46 |
| Completed | 42 |
| Not completed | 4 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Withdrawal by subject | 1 |
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
| percentage of participants | CHOP + RT + Zevalin |
|---|---|
| Progression-free Survival | 89 (76 to 95) |
Collected over After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHOP + RT + Zevalin | — | 0/46 (0%) | 44/46 (95.7%) |
| Event | CHOP + RT + Zevalin |
|---|---|
| Fatigue (asthenia, lethargy, malaise)General disorders | 33/46 |
| Leukocytes (total WBC)Investigations | 29/46 |
| HemoglobinBlood and lymphatic system disorders | 28/46 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 27/46 |
| PlateletsInvestigations | 25/46 |
| Hair loss/Alopecia (scalp or body)Skin and subcutaneous tissue disorders | 24/46 |
| NauseaGastrointestinal disorders | 21/46 |
| LymphopeniaInvestigations | 19/46 |
| ConstipationGastrointestinal disorders | 16/46 |
| Rash: dermatitis associated with radiation - RadiationInjury, poisoning and procedural complications | 16/46 |
| Age, Continuous(years) | CHOP + RT + Zevalin |
|---|---|
| Median | 61.2 (23.5 to 84.6) |
| Sex: Female, Male(Participants) | CHOP + RT + Zevalin |
|---|---|
| Female | 16 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | CHOP + RT + Zevalin |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 38 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | CHOP + RT + Zevalin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 42 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SWOG Cancer Research Network