Lymphoma, B-CellPhase 2NCT00216164
Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Rituximab and Gemcitabine in people with Lymphoma, B-Cell, run by Hoosier Cancer Research Network at 9 sites in United States.
Trial summary
Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- Rituximab and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2005to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups
- Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4 subgroups and have received at least one standard chemotherapy regimen for aggressive NHL or a biopsy upon progression of disease has been obtained to confirm the presence of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT exclude participation
- Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma
- Prior gemcitabine therapy is allowed.
- Negative pregnancy test
Who cannot join
- No history of life-threatening reactions to rituximab.
- No history of gemcitabine intolerance; prior gemcitabine therapy is allowed.
- No history of malignancy in the last 5 years (basal cell carcinoma of the skin excluded).
- No central nervous system or cerebrospinal fluid involvement
- No other investigational drugs received within 30 days prior to being registered for protocol therapy.
- No active infections.
- No current breastfeeding
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Elkhart Clinic
Elkhart, Indiana, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, 47150
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Providence Medical Group
Terre Haute, Indiana, 47802
AP&S Clinic
Terre Haute, Indiana, 47804
About this study
Official title: Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64
Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit.
This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.
Read the detailed description
OUTLINE: This is a multi-center study.
- Rituximab 375 mg/m2 day 1 of 21 day cycle
- Gemcitabine 1000 mg/m2 days 1 and 8 of 21 day cycle
Subgroup 1. Relapsed after responding to first line chemotherapy, who are not candidates for salvage high-dose chemotherapy.
Subgroup 2. Failure to achieve a complete response or relapsed after responding to salvage chemotherapy (any number of salvage regimens allowed), who are not candidates for high-dose chemotherapy.
Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy regimen.
Subgroup 4. Progression after high-dose chemotherapy. Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed.
Performance Status: ECOG performance status 0, 1, 2
Life expectancy: Not specified
Hematopoietic:·
- ANC ≥ 1,000/mm3·
- Platelets ≥ 100,000/mm3
Hepatic:·
- Total bilirubin ≤ 2.0 x ULN·
- ALT and AST ≤ 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be < 5 x ULN
Renal:·
- Serum creatinine ≤ 2.0 mg/dl (except for patients on dialysis)
Cardiovascular:·
- Not specified
Pulmonary:·
- Not specified
- Conditions
- Lymphoma, B-Cell
- Being tested
- Rituximab, Gemcitabine
- Keywords
- Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab 375 mg/m2, day 1 of 21 day cycle
GemcitabineDrug
Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Receives: Drug: Rituximab; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
Measured: 18 months
Secondary outcomes (1)
· Evaluate toxicity, time to progression and overall survival.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: Study terminated due to lack of response at the first efficacy analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Walther Cancer Institute
- Investigators
- Michael Robertson, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216164
- Sponsor's protocol ID
- HOG LYM03-64
- Status last verified
- Apr 2011
- First submitted
- 12 Sep 2005
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64
- ClinicalTrials.gov ID
- NCT00216164
- Acronym / sponsor ID
- HOG LYM03-64
- Conditions
- Lymphoma, B-Cell
- Keywords
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of response at the first efficacy analysis
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Walther Cancer Institute
- Study start
- Apr 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit.
This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.
Detailed description
OUTLINE: This is a multi-center study.
- Rituximab 375 mg/m2 day 1 of 21 day cycle
- Gemcitabine 1000 mg/m2 days 1 and 8 of 21 day cycle
Subgroup 1. Relapsed after responding to first line chemotherapy, who are not candidates for salvage high-dose chemotherapy.
Subgroup 2. Failure to achieve a complete response or relapsed after responding to salvage chemotherapy (any number of salvage regimens allowed), who are not candidates for high-dose chemotherapy.
Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy regimen.
Subgroup 4. Progression after high-dose chemotherapy. Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed.
Performance Status: ECOG performance status 0, 1, 2
Life expectancy: Not specified
Hematopoietic:·
- ANC ≥ 1,000/mm3·
- Platelets ≥ 100,000/mm3
Hepatic:·
- Total bilirubin ≤ 2.0 x ULN·
- ALT and AST ≤ 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be < 5 x ULN
Renal:·
- Serum creatinine ≤ 2.0 mg/dl (except for patients on dialysis)
Cardiovascular:·
- Not specified
Pulmonary:·
- Not specified
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rituximab, Drug: GemcitabineRituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups
- Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4 subgroups and have received at least one standard chemotherapy regimen for aggressive NHL or a biopsy upon progression of disease has been obtained to confirm the presence of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT exclude participation
- Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma
- Prior gemcitabine therapy is allowed.
- Negative pregnancy test
Key exclusion criteria (7 listed)
- No history of life-threatening reactions to rituximab.
- No history of gemcitabine intolerance; prior gemcitabine therapy is allowed.
- No history of malignancy in the last 5 years (basal cell carcinoma of the skin excluded).
- No central nervous system or cerebrospinal fluid involvement
- No other investigational drugs received within 30 days prior to being registered for protocol therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabRituximab 375 mg/m2, day 1 of 21 day cycle | Drug | 1 |
| GemcitabineGemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle | Drug | 1 |
Primary outcome
· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
Time frame: 18 months
1 secondary outcome
· Evaluate toxicity, time to progression and overall survival.
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Study terminated due to lack of response at the first efficacy analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Robertson, M.D. study chair
Hoosier Oncology Group, LLC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab and Gemcitabine in people with Lymphoma, B-Cell, run by Hoosier Cancer Research Network at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of response at the first efficacy analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.