A Phase 2 interventional study of filgrastim and rituximab in Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-08-10.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.
OUTLINE: Patients are stratified according to risk (low-intermediate vs high-intermediate or high).
Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV over 15 minutes, and vincristine IV over 1-2 minutes on day 1; oral prednisone once daily on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) once daily on days 7-11 or PEG-filgrastim once at least 24 hours after infusion. Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy. Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
After the completion of induction chemotherapy, patients undergo CT scan and positron emission tomography (PET) scanning. If the PET scan is positive in one or more nodal sites, a repeat biopsy is performed. Patients with a negative PET scan OR a negative repeat biopsy (including no evidence of lymphoma on repeat bone marrow biopsy) are assigned to receive regimen A for consolidation therapy. Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy.
Patients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation. All patients are followed closely for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 40-98 patients will be accrued for this study within 4 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 98 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy.
Biological: filgrastim · Biological: rituximab · Drug: carboplatin · Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: etoposide · Drug: ifosfamide · Drug: prednisone · Drug: vincristine sulfate · Procedure: peripheral blood stem cell transplantation · Radiation: radiation therapy
Progression Free Survival
Kaplan-Meier estimates will be used to verify the progression free survival.
Time frame: 2 years
| Milestone | Induction R-CHOPac Therapy |
|---|---|
| Started | 98 |
| Completed | 98 |
| Not completed | 0 |
Kaplan-Meier estimates will be used to verify the progression free survival.
| percentage of patients progression free | Induction R-CHOPac Therapy |
|---|---|
| Progression Free Survival | 79 (69 to 89) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction R-CHOPac Therapy | — | 20/98 (20.4%) | 98/98 (100%) |
| Event | Induction R-CHOPac Therapy |
|---|---|
| Febrile neutropeniaGeneral disorders | 8/98 |
| ThrombosisRespiratory, thoracic and mediastinal disorders | 4/98 |
| Infection without neutropeniaInfections and infestations | 3/98 |
| GI, otherGastrointestinal disorders | 2/98 |
| HypotensionCardiac disorders | 2/98 |
| NeutrophilsBlood and lymphatic system disorders | 2/98 |
| PlateletsBlood and lymphatic system disorders | 2/98 |
| Abdominal pain/crampingGastrointestinal disorders | 1/98 |
| ArachnoiditisMusculoskeletal and connective tissue disorders | 1/98 |
| Constitutional symptoms, otherGeneral disorders | 1/98 |
| Event | Induction R-CHOPac Therapy |
|---|---|
| LymphopeniaBlood and lymphatic system disorders | 94/98 |
| Hemoglobin (Hgb)Blood and lymphatic system disorders | 89/98 |
| HyperglycemiaMetabolism and nutrition disorders | 79/98 |
| PlateletsBlood and lymphatic system disorders | 70/98 |
| LeukocytesBlood and lymphatic system disorders | 68/98 |
| NeutrophilsBlood and lymphatic system disorders | 64/98 |
| HypocalcemiaMetabolism and nutrition disorders | 41/98 |
| HypophosphatemiaMetabolism and nutrition disorders | 33/98 |
| SGPT (ALT)Blood and lymphatic system disorders | 30/98 |
| SGOT (AST)Blood and lymphatic system disorders | 22/98 |
| Age, Categorical(Participants) | Induction R-CHOPac Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 97 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Induction R-CHOPac Therapy |
|---|---|
| Female | 42 |
| Male | 56 |
| Region of Enrollment(participants) | Induction R-CHOPac Therapy |
|---|---|
| United States | 98 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center