Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 85 of 179 for:    "Lymphomatoid Granulomatosis"

Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00072514
Recruitment Status : Completed
First Posted : November 5, 2003
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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
Interventions Drug: gemcitabine hydrochloride
Drug: carboplatin
Drug: dexamethasone
Biological: rituximab
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 55
Completed 51
Not Completed 4
Arm/Group Title Treatment
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants
58
(19 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
21
  41.2%
Male
30
  58.8%
1.Primary Outcome
Title Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules
Hide Description 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%.
Time Frame At 3-4 weeks after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
51
 100.0%
2.Secondary Outcome
Title Overall and Complete Response Rates
Hide Description 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.)
Time Frame 3-4 weeks after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Overall
67
(54 to 80)
Complete
31
(19 to 44)
3.Secondary Outcome
Title Hematologic and Non-hematologic Adverse Events.
Hide Description Count of participants with grade 3/4 hematologic and non-hematologic adverse events.
Time Frame 3-4 weeks after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
Hematologic Grade 3
10
  19.6%
Hematologic Grade 4
39
  76.5%
Non-Hematologic Grade 3
23
  45.1%
Non-Hematologic Grade 4
2
   3.9%
4.Secondary Outcome
Title Peripheral Blood Stem Cell Collection
Hide Description Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Successful PBSC collection is only considered in those patients that attempted PBSC collection.
Arm/Group Title Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
Attempted PBSC Collection Number Analyzed 51 participants
17
  33.3%
Successful PBSC Collection Number Analyzed 17 participants
17
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%)
Total   45/51 (88.24%) 
Blood and lymphatic system disorders   
Neutrophils  38/51 (74.51%) 
Hemoglobin  18/51 (35.29%) 
Hemorrhage  5/51 (9.80%) 
Platelets  45/51 (88.24%) 
Thromboses  3/51 (5.88%) 
Gastrointestinal disorders   
GI  4/51 (7.84%) 
General disorders   
Constitutional  5/51 (9.80%) 
Pain  6/51 (11.76%) 
Infections and infestations   
Infection  12/51 (23.53%) 
Metabolism and nutrition disorders   
Matabolic/Laboratory  11/51 (21.57%) 
Nervous system disorders   
Neurology  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary  3/51 (5.88%) 
Vascular disorders   
Hypotension  3/51 (5.88%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
Responsible Party: Ajay Gopal, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00072514     History of Changes
Other Study ID Numbers: PSOC 2003
NCI-2011-00035 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 4, 2003
First Posted: November 5, 2003
Results First Submitted: April 14, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017