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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00078949 |
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: cisplatin Drug: cytarabine Drug: dexamethasone Drug: gemcitabine hydrochloride Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) Compared To Dexamethasone, Cytarabine, And Cisplatin (DHAP) As Salvage Chemotherapy For Patients With Relapsed Or Refractory Aggresive Histology Non-Hodgkin's Lymphoma Prior To Autologous Stem Cell Transplant And Followed By Maintenance Rituximab Versus Observation |
Estimated Enrollment: | 630 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Salvage arm I: Experimental
Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
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Drug: cisplatin
Given IV
Drug: dexamethasone
Given IV
Drug: gemcitabine hydrochloride
Given IV
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Salvage arm II: Experimental
Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
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Drug: cisplatin
Given IV
Drug: cytarabine
Given IV
Drug: dexamethasone
Given IV
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Maintenance arm I: Experimental
Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
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Procedure: observation
No treatment given in maintenance phase
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Maintenance arm II: No Intervention
Patients undergo observation only.
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Biological: rituximab
Given IV
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Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
Prior indolent lymphoma (e.g., follicular center cell lymphoma; marginal zone lymphoma, including extranodal mucosa-associated lymphoid tissue [MALT] lymphoma; and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse
Clinically or radiologically documented disease meeting either of the following criteria:
Measurable disease, defined as at least 1 bidimensionally measurable site of disease using clinical exam, CT scan, or MRI
Evaluable disease, defined as only nonmeasurable disease, including any of the following:
No uncontrolled CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
At least 4 weeks since prior radiotherapy and recovered
Surgery
Other
Study Chair: | Michael R. Crump, MD, FRCPC | Princess Margaret Hospital, Canada |
Investigator: | Massimo Federico, MD | Azienda Ospedaliera - Universitaria di Modena |
Study ID Numbers: | CDR0000353203, CAN-NCIC-LY12 |
Study First Received: | March 8, 2004 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00078949 History of Changes |
Health Authority: | Unspecified |
anaplastic large cell lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma angioimmunoblastic T-cell lymphoma |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Lymphoma, Small Cleaved-cell, Diffuse Cisplatin Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Aggression Lymphoma, Large-cell Gemcitabine |
Lymphoma Cytarabine Dexamethasone acetate Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Immunoblastic Lymphadenopathy Glucocorticoids Immunosuppressive Agents Antiviral Agents Recurrence Lymphatic Diseases Burkitt's Lymphoma Radiation-Sensitizing Agents |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Cisplatin Therapeutic Uses Gemcitabine |
Lymphoma Cytarabine Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases |