Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
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ClinicalTrials.gov Identifier: NCT00072514 |
Recruitment Status :
Completed
First Posted : November 5, 2003
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
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Condition or disease | Intervention/treatment | Phase |
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Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Noncutaneous Extranodal Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Testicular Lymphoma Waldenstrom Macroglobulinemia | Drug: gemcitabine hydrochloride Drug: carboplatin Drug: dexamethasone Biological: rituximab | Phase 2 |
OBJECTIVES:
I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or without Rituximab in previously treated lymphoid malignancies (rituximab will only be evaluated in CD20 positive malignancies).
II. To determine the efficacy of the above regimen.
III. To determine the ability to proceed to blood stem peripheral blood collection following the above regimens (the impact of above regimen on stem cell reserve).
IV. To determine remission duration.
All patients are treated with gemcitbine, carboplatin, and dexamethasone. Patients with CD20 + lymphomas also receive rituximab.
After completion of study treatment, patients are followed up at 3-4 weeks and then every 6 months for 5 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
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Experimental: Treatment
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
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Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: carboplatin Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Biological: rituximab Given IV in CD20-POSITIVE LYMPHOMAS cases
Other Names:
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- Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules [ Time Frame: At 3-4 weeks after completion of study treatment ]Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.
- Overall and Complete Response Rates [ Time Frame: 3-4 weeks after completion of study treatment ]Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)
- Hematologic and Non-hematologic Adverse Events. [ Time Frame: 3-4 weeks after completion of study treatment ]Count of participants with grade 3/4 hematologic and non-hematologic adverse events.
- Peripheral Blood Stem Cell Collection [ Time Frame: Up to 12 weeks ]Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin's Disease)
- Revised European American classification (REAL), or World Health Organization (WHO) classification of patients malignancies must be provided
- Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm; Note: CT scans remain the standard for evaluation of nodal disease
- Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
- Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck
- Patients should not have evidence active central nervous system lymphoma
- Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2
- Patients should have absolute neutrophil count (ANC) >= 1,500/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
- Patients should have platelets >= 100,000/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
- Serum bilirubin less than 2 times the upper limit of normal
- Serum creatinine less than 1.5 times the upper limit of normal and creatinine clearance greater than 50/ mL per minute
- Patients must have serum lactate dehydrogenase (LDH) performed within 14 days prior to treatment
- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
- Must anticipate that patient will complete at least 2 cycles of chemotherapy
Exclusion Criteria:
- Patients known to be human immunodeficiency virus (HIV) positive
- Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater unless approved by the Principal Investigator (PI)
- Patients that are refractory (i.e., not responded or progressed within 6 months) to a carboplatin or cisplatin-based regimen or a gemcitabine-based regimen
- Patients with active hepatitis B virus (HBV) infection or hepatitis
- Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy

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): NCT00072514
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Ajay Gopal | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
Responsible Party: | Ajay Gopal, Principal Investigator, Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00072514 |
Other Study ID Numbers: |
PSOC 2003 NCI-2011-00035 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | November 5, 2003 Key Record Dates |
Results First Posted: | June 29, 2017 |
Last Update Posted: | June 29, 2017 |
Last Verified: | May 2017 |
Mycoses Burkitt Lymphoma Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Hodgkin Disease Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma |
Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Waldenstrom Macroglobulinemia Lymphoma, Large-Cell, Anaplastic Lymphoma, T-Cell, Peripheral Lymphomatoid Granulomatosis Lymphoma, Extranodal NK-T-Cell Intraocular Lymphoma Immunoblastic Lymphadenopathy Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |