Completed

A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

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What is being tested

gemcitabine hydrochloride

+ carboplatin
+ dexamethasone
Drug
Biological
Who is being recruted

Plasmablastic Lymphoma
+56

+ Lymphadenopathy
+ Bacterial Infections and Mycoses
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies 
NCT00072514
Principal SponsorFred Hutchinson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
55 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Plasmablastic Lymphoma
Lymphadenopathy
Bacterial Infections and Mycoses
Blood Protein Disorders
Burkitt Lymphoma
Cardiovascular Diseases
Chronic Disease
DNA Virus Infections
Eye Neoplasms
Hematologic Diseases
Hemorrhagic Disorders
Herpesviridae Infections
Hodgkin Disease
Immunoblastic Lymphadenopathy
Immune System Diseases
Immunoproliferative Disorders
Infections
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphomatoid Granulomatosis
Lymphoproliferative Disorders
Waldenstrom Macroglobulinemia
Mycoses
Mycosis Fungoides
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Paraproteinemias
Pathologic Processes
Precancerous Conditions
Recurrence
Sezary Syndrome
Tumor Virus Infections
Vascular Diseases
Virus Diseases
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoma, B-Cell, Marginal Zone
Epstein-Barr Virus Infections
Hemostatic Disorders
Lymphoma, Mantle-Cell
Disease Attributes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms, Plasma Cell
Lymphoma, Extranodal NK-T-Cell
Intraocular Lymphoma
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.

Given IV

Given IV

Given PO

Given IV in CD20-POSITIVE LYMPHOMAS cases
Study Objectives
Primary Objectives

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%.
Secondary Objectives

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.)

Count of participants with grade 3/4 hematologic and non-hematologic adverse events.

Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, United StatesSee the location

CompletedOne Study Center
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