Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00007852 |
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Recruitment Status
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Completed
First Posted
: February 12, 2004
Last Update Posted
: March 26, 2012
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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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: rituximab Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: autologous hematopoietic stem cell transplantation | Phase 2 |
OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine, etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation. II. Determine the toxicity profile of this regimen in these patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with patient outcomes in this patient population.
OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days -5 to -2, and melphalan IV on day -1. On day 0 patients undergo autologous bone marrow or peripheral blood stem cell transplantation. After transplantation, patients receive a fourth dose of rituximab as above at approximately day 30, and then weekly over 4 weeks at approximately 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Lymphoma |
| Study Start Date : | September 2000 |
| Actual Primary Completion Date : | January 2002 |
| Actual Study Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Rituxan and BEAM with autologous stem cell transplant
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Biological: rituximab
Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.
Other Name: Rituxan
Drug: carmustine
BCNU 300 mg/M2 IV day -6
Other Name: BCNU
Drug: cytarabine
100 mg/m2 on days -5 through -2
Other Name: BEAM chemotherapy regimen
Drug: etoposide
100mg/M2 BID on days -5 through -2
Other Name: BEAM chemotherapy regimen
Drug: melphalan
140 mg/m2 IV on day -1
Other Name: BEAM chemotherapy regimen
Procedure: autologous hematopoietic stem cell transplantation
Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
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- The primary endpoint for this study is 100 day (complete + partial) response rate [ Time Frame: 100 days ]
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| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma Transplantation candidate Primary induction failure Chemotherapy refractory disease Received at least 3 prior chemotherapy regimens OR Diagnosis of mantle cell lymphoma No history of T-cell lymphoma No relapse or progression after rituximab therapy within 3 months before transplantation
PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3* Platelet count more than 50,000/mm3* Hemoglobin more than 9.0 g/dL* *Unless due to lymphomatous involvement of the marrow Hepatic: Not specified Renal: Not specified Other: No serious disease or condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for transient control or prevention of nausea or vomiting Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed Radiotherapy: No concurrent external beam radiotherapy during transplantation therapy Surgery: Not specified Other: No other concurrent antitumoral or investigational agents
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007852
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| Study Chair: | Julie M. Vose, MD | University of Nebraska |
| Responsible Party: | Julie M Vose, MD, Professor & N/M Harris Oncology Professorship, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00007852 History of Changes |
| Other Study ID Numbers: |
045-00 P30CA036727 ( U.S. NIH Grant/Contract ) UNMC-045-00 NCI-V00-1634 |
| First Posted: | February 12, 2004 Key Record Dates |
| Last Update Posted: | March 26, 2012 |
| Last Verified: | March 2012 |
Keywords provided by Julie M Vose, MD, University of Nebraska:
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recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Additional relevant MeSH terms:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Etoposide Cytarabine Melphalan Carmustine Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |
Antirheumatic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists |