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Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
rituximab
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
ifosfamide
prednisone
vincristine sulfate
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed aggressive diffuse large B-cell lymphoma CD20-positive disease Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following: Karnofsky performance status 10-70% Lactate dehydrogenase greater than 200 U/L Stage III or IV disease Positron emission tomography avid measurable disease No CNS involvement PATIENT CHARACTERISTICS: Age: 18 to 64 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease Hepatitis B surface antigen and hepatitis C antibody negative No chronic, active, or persistent hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min No chronic renal insufficiency Cardiovascular: Ejection fraction at least 50% by echocardiogram or MUGA scan No myocardial infarction within the past 6 months No unstable angina No cardiac arrhythmias except chronic atrial fibrillation Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No other medical illness that would preclude study No uncontrolled infection No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for malignancy Chemotherapy: No prior chemotherapy for malignancy Endocrine therapy: Prior steroids allowed if received no more than 1 week of therapy Radiotherapy: No prior radiotherapy for malignancy Surgery: No prior surgery for malignancy Other: No other prior therapy for malignancy

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction R-CHOPac Therapy for patients with B-Cell Lymphoma

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression Free Survival
Kaplan-Meier estimates will be used to verify the progression free survival.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
June 29, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Bristol-Myers Squibb, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00039195
Brief Title
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Official Title
Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Bristol-Myers Squibb, Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. Regimen A: Patients receive consolidation chemotherapy comprising etoposide IV over 1 hour on days 1-3, ifosfamide IV continuously over 24 hours on day 2, carboplatin IV on day 2, and G-CSF SC once daily on days 5-12 or PEG-filgrastim once at least 24 hours after infusion. Treatment repeats every 14 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Regimen B: Patients receive consolidation chemotherapy as in regimen A for 3 courses. Patients also receive rituximab IV on days -3 to -1 of course 3 of chemotherapy. Patients undergo leukapheresis at the completion of course 3 (G-CSF continues from day 5 until the end of leukapheresis). After completion of leukapheresis, patients begin a regimen of high-dose chemoradiotherapy comprising either total body irradiation twice daily on days -10 to -7 and ifosfamide IV over 1 hour and etoposide IV continuously on days -6 to -2 or BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and melphalan. Autologous peripheral blood stem cells (APBSC) are reinfused on day 0. Patients also receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover. Beginning on day 42 post-APBSC, if blood counts have recovered, patients receive rituximab IV once weekly for 4 weeks. Rituximab is repeated beginning on day 180 in the absence of disease progression. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Kaplan-Meier estimates will be used to verify the progression free survival.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed aggressive diffuse large B-cell lymphoma CD20-positive disease Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following: Karnofsky performance status 10-70% Lactate dehydrogenase greater than 200 U/L Stage III or IV disease Positron emission tomography avid measurable disease No CNS involvement PATIENT CHARACTERISTICS: Age: 18 to 64 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease Hepatitis B surface antigen and hepatitis C antibody negative No chronic, active, or persistent hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min No chronic renal insufficiency Cardiovascular: Ejection fraction at least 50% by echocardiogram or MUGA scan No myocardial infarction within the past 6 months No unstable angina No cardiac arrhythmias except chronic atrial fibrillation Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No other medical illness that would preclude study No uncontrolled infection No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for malignancy Chemotherapy: No prior chemotherapy for malignancy Endocrine therapy: Prior steroids allowed if received no more than 1 week of therapy Radiotherapy: No prior radiotherapy for malignancy Surgery: No prior surgery for malignancy Other: No other prior therapy for malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Moskowitz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma

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