A Phase 2 interventional study of rituximab and cyclophosphamide in Lymphoma, sponsored by Eastern Cooperative Oncology Group. Terminated at 153 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Eastern Cooperative Oncology Group · Phase 2, Interventional, and Treatment
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.
OBJECTIVES:
OUTLINE: This is a pilot, multicenter study.
Patients receive rituximab intravenously (IV) over approximately 4 hours, cyclophosphamide IV over 5-30 minutes, doxorubicin IV over 5-15 minutes, and vincristine IV over 1 minute on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
ACTUAL ACCRUAL: A total of 16 patients were accrued for this study.
365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the following:
Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma, defined by 1 of the following:
Must be symptomatic with 1 of the following:
History of heart disease allowed only if 1 of the following is demonstrated by echocardiography, multigated acquisition scan (MUGA), exercise MUGA, or coronary catheterization:
EXCLUSION CRITERIA:
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by: Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
Biological: rituximab · Drug: cyclophosphamide · Drug: Doxorubicin · Drug: Prednisone · Drug: Vincristine
Rituximab is given intravenously. The initial rate is 50 mg/hr for the 1st hour. If no toxicity, the rate may be escalated in 50 mg/hr increments at 30-minute intervals to a maximum of 400 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr. If the patient experiences fever and rigors, the antibody infusion is discontinued. The severity of the side effects should be evaluated. If the symptoms improve, the infusion is continued initially at half the previous rate. Following the antibody infusion, the intravenous line should be maintained for medications as needed. If there are no complications after one hour of observation, the intravenous line may be discontinued.
Also known as: IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody, Rituxan, NSC# 687451
Cyclophosphamide will be given at a dosage of 750 mg/m² intravenously on day 1 of each cycle (1 cycle =21 days) for 6 cycles. Dose is based on surface area calculated based on actual body weight. The drug should be administered as a rapid IV infusion over 5 to 30 minutes.
Also known as: Cytoxan, CTX, CPM, Neosar
Doxorubicin will be given intravenously at a dosage of 50 mg/m² on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Doxorubicin should be administered as a continuous infusion into tubing of a freely flowing intravenous line for 5 -15 minutes. Avoid extravasation.
Also known as: Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin, ADR
Prednisone will be administered at 100 mg/m² orally, days 1-5 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
Also known as: Deltasone, Orasone, Medicortone, Panasol-S, Liqui-Pred
Vincristine will be administered 1.4 mg/m² intravenously (Maximum dose = 2.0 mg) on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Given as IV push over 1 minute, using extravasation precautions.
Also known as: Vinsacar PFS, vincristine sulfate, VCR, leucocristine, LCR
Objective Response to Treatment
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
Time frame: Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
The study was activated on June 15, 2004, accrued its first patient on October 5, 2004, and closed due to slow accrual on April 26, 2007. Sixteen patients were accrued in this trial from Eastern Cooperative Oncology Group (ECOG) and Southwest Oncology Group (SWOG) institutions.
| Milestone | Rituximab + CHOP |
|---|---|
| Started | 16 |
| Eligible and treated | 16 |
| Completed | 16 |
| Not completed | 0 |
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
| proportion of participants | Rituximab + CHOP |
|---|---|
| Objective Response to Treatment | 0.938 (0.736 to 0.997) |
Collected over Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab + CHOP | — | 16/16 (100%) | 16/16 (100%) |
| Event | Rituximab + CHOP |
|---|---|
| NeutropeniaInvestigations | 13/16 |
| LeukopeniaInvestigations | 8/16 |
| LymphopeniaInvestigations | 8/16 |
| Infection w/ Gr3-4 neutropeniaInfections and infestations | 3/16 |
| HypotensionVascular disorders | 2/16 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/16 |
| Neuropathy-sensoryNervous system disorders | 2/16 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/16 |
| Allergic reactionImmune system disorders | 1/16 |
| AnemiaBlood and lymphatic system disorders | 1/16 |
| Event | Rituximab + CHOP |
|---|---|
| LeukopeniaInvestigations | 16/16 |
| LymphopeniaInvestigations | 15/16 |
| NeutropeniaInvestigations | 15/16 |
| AnemiaBlood and lymphatic system disorders | 14/16 |
| FatigueGeneral disorders | 14/16 |
| Neuropathy-sensoryNervous system disorders | 11/16 |
| AlopeciaSkin and subcutaneous tissue disorders | 9/16 |
| HyperglycemiaMetabolism and nutrition disorders | 9/16 |
| ThrombocytopeniaInvestigations | 8/16 |
| NauseaGastrointestinal disorders | 6/16 |
| Age, Continuous(years) | Rituximab + CHOP |
|---|---|
| Median | 59.5 (44.1 to 78.6) |
| Sex: Female, Male(Participants) | Rituximab + CHOP |
|---|---|
| Female | 6 |
| Male | 10 |
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Waldenstrom Macroglobulinemia→
Eastern Cooperative Oncology Group