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Alkylating agents
S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Phase 2
Waitlist Available
Led By Daniel O. Persky, MD
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 30 Other Conditions
Summary
This trial will compare PET-directed chemotherapy to standard chemotherapy in treating patients with limited-stage diffuse large B-cell lymphoma.
Eligible Conditions
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Secondary study objectives
Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PET Positive: IFRT +ZevalinExperimental Treatment5 Interventions
Standard IFRT+ Zevalin IV per ABW
Group II: PET Negative: R-CHOPActive Control7 Interventions
R-CHOP x 3 Cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
fludeoxyglucose F 18
2005
Completed Phase 3
~3970
selective external radiation therapy
2011
Completed Phase 2
~160
yttrium Y 90 ibritumomab tiuxetan
2012
Completed Phase 2
~750
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,457 Total Patients Enrolled
37 Trials studying Lymphoma
6,901 Patients Enrolled for Lymphoma
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,042 Total Patients Enrolled
36 Trials studying Lymphoma
6,674 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,421 Total Patients Enrolled
1,410 Trials studying Lymphoma
383,609 Patients Enrolled for Lymphoma
Daniel O. Persky, MDPrincipal InvestigatorYale University
5 Previous Clinical Trials
454 Total Patients Enrolled
5 Trials studying Lymphoma
454 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients with a specific type of lymphoma called limited-stage DLBCL, which can be measured or evaluated.The type of CT scans used for this study must be of higher quality and show clear details.You have primary mediastinal lymphoma or testicular lymphoma, which means you cannot participate.
Research Study Groups:
This trial has the following groups:- Group 1: PET Negative: R-CHOP
- Group 2: PET Positive: IFRT +Zevalin
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.