Cytoreduction and Stem Cell Mobilization With Rituximab and ICE for Patients With Refractory or Relapsed CD20+ B-Cell IGL Eligible for ASCT: The RICE Protocol
18 Years
72 Years
Both
Lymphoma
Trial Information
Cytoreduction and Stem Cell Mobilization With Rituximab and ICE for Patients With Refractory or Relapsed CD20+ B-Cell IGL Eligible for ASCT: The RICE Protocol
OBJECTIVES: I. Determine the complete response rate in patients with relapsed or refractory
CD20-positive diffuse large cell, immunoblastic, or anaplastic large cell lymphoma treated
with cytoreduction and mobilization with rituximab, ifosfamide, carboplatin, and etoposide
(RICE). II. Assess the ability of this regimen to deplete the stem cell harvest of B-cells
and tumor cells in these patients. III. Assess the efficacy of this regimen to mobilize
peripheral blood progenitor cells in these patients. IV. Assess the safety and toxicity of
this regimen in these patients.
OUTLINE: Cytoreduction and mobilization: Patients receive ifosfamide IV over 24 hours and
carboplatin IV on day 4 and etoposide IV over 1 hour on days 3-5. Chemotherapy repeats every
2 weeks for 3 courses. Patients receive rituximab IV on day -2 before initiation of
chemotherapy and on day 1 of each course of chemotherapy. Patients receive filgrastim
(G-CSF) subcutaneously (SC) daily on days 7-14 of each course of chemotherapy. Patients with
complete or partial response after completion of course 3 continue to receive G-CSF SC daily
until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are
harvested and selected for CD34+ cells. If sufficient numbers of CD34+ cells are not
obtained, patients undergo bone marrow harvest.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma that is in first
relapse or refractory to primary therapy Eligible types: Diffuse large cell Immunoblastic
Anaplastic large cell Eligible for autologous peripheral blood stem cell transplantation
CD20-positive disease Measurable disease No brain parenchyma involvement
PATIENT CHARACTERISTICS: Age: 18 to 72 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet
count greater than 50,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL unless due to
Gilbert's disease No chronic or persistent hepatitis Hepatitis B surface antigen negative
Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
No chronic renal insufficiency Cardiovascular: Normal baseline cardiac function 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 malignancy within the past 5 years except
basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled
infection
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior rituximab
allowed Chemotherapy: No prior carboplatin or cisplatin Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Craig Moskowitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
99-092
NCT ID:
NCT00005631
Start Date:
November 1999
Completion Date:
November 2002
Related Keywords:
- Lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- anaplastic large cell lymphoma
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
