Refractory Aggressive Non-Hodgkin's LymphomaPhase 2NCT01538641
Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas
A Phase 2 study testing Rituximab, Gemcitabine, Oxaliplatin in people with Refractory Aggressive Non-Hodgkin's Lymphoma and Relapsing Aggressive Non-Hodgkin's Lymphoma, run by Auxilio Mutuo Cancer Center.
Trial summary
Study Proposal: Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Aggressive Non-Hodgkin's Lymphoma, Relapsing Aggressive Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab, Gemcitabine, Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Dec 2008
- 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
- Patients with refractory or relapsed aggressive non-Hodgkin's Lymphoma. The definition of refractory includes patients who either did not respond to prior therapy or those whose best response was a PR after at least 4 courses of chemotherapy. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
- Histologic or cytological confirmation of refractory or relapsed aggressive non-Hodgkin's Lymphoma is desirable but not mandatory and will be left to the discretion of the investigator.
- Must have measurable or evaluable disease.
- No more than 4 previous regimens of chemotherapy will be allowed, including stem cell or bone marrow transplant.
- Patients must be more than 18 years old.
- No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
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- Written Consent
- Those patients who have previously received a platinum or nucleoside analogue-containing regimen are eligible.
- Patients who are candidates for stem cell or marrow transplant will be included
Who cannot join
- Patients with a previous or concurrent history of cancer with the exception of: 1-treated carcinoma in situ of cervix or breast. 2- treated squamous or basal cell skin cancer, or 3- any other surgically cured malignancy from which the patient has been disease free for at least 5 years.
- HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
- Patients with severe neuropathy will be excluded.
- Chemotherapy or Radiotherapy within the previous 3 weeks prior to entering study.
About this study
Official title: Phase II Evaluation Of GROC (Gemcitabine- Rituximab-Oxaliplatin Combination) Given Every 14 Days For The Treatment Of Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
Study Proposal:
Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be explored in this group of disorders. Based on these data and considering the advantage of its favorable toxicity profile, we propose a phase II study in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including peripheral T-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive B-cell lymphomas.
- Being tested
- Rituximab, Gemcitabine, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Gemcitabine, OxaliplatinDrug
Rituximab:375 mg/m2; on day 1 of each 14 days cycle. Gemcitabine:1,000 mg/m2 on day 2 of each 14 days cycle. Oxaliplatin:100 mg/m2; on day 2 of each 14 days cycle. Total number of cycles: 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rituximab, Gemcitabine, Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate of the combination of Gemcitabine-Oxaliplatin-Rituximab.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startOct 2003
- Primary completionAug 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Aggressive Non-Hodgkin's LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auxilio Mutuo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Cabanillas, Auxilio Mutuo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538641
- Sponsor's protocol ID
- CCAM-03-01
- Status last verified
- Jul 2012
- First submitted
- 21 Feb 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation Of GROC (Gemcitabine- Rituximab-Oxaliplatin Combination) Given Every 14 Days For The Treatment Of Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01538641
- Acronym / sponsor ID
- CCAM-03-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Auxilio Mutuo Cancer CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Feb 2012 (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.
Study Proposal:
Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be explored in this group of disorders. Based on these data and considering the advantage of its favorable toxicity profile, we propose a phase II study in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including peripheral T-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive B-cell lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rituximab, Gemcitabine, Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with refractory or relapsed aggressive non-Hodgkin's Lymphoma. The definition of refractory includes patients who either did not respond to prior therapy or those whose best response was a PR after at least 4 courses of chemotherapy. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
- Histologic or cytological confirmation of refractory or relapsed aggressive non-Hodgkin's Lymphoma is desirable but not mandatory and will be left to the discretion of the investigator.
- Must have measurable or evaluable disease.
- No more than 4 previous regimens of chemotherapy will be allowed, including stem cell or bone marrow transplant.
- Patients must be more than 18 years old.
Key exclusion criteria (4 listed)
- Patients with a previous or concurrent history of cancer with the exception of: 1-treated carcinoma in situ of cervix or breast. 2- treated squamous or basal cell skin cancer, or 3- any other surgically cured malignancy from which the patient has been disease free for at least 5 years.
- HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
- Patients with severe neuropathy will be excluded.
- Chemotherapy or Radiotherapy within the previous 3 weeks prior to entering study.
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 |
|---|---|---|
| Rituximab, Gemcitabine, OxaliplatinRituximab:375 mg/m2; on day 1 of each 14 days cycle. Gemcitabine:1,000 mg/m2 on day 2 of each 14 days cycle. Oxaliplatin:100 mg/m2; on day 2 of each 14 days cycle. Total number of cycles: 6 cycles. | Drug | 1 |
Primary outcome
The response rate of the combination of Gemcitabine-Oxaliplatin-Rituximab.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Gemcitabine, Oxaliplatin in people with Refractory Aggressive Non-Hodgkin's Lymphoma and Relapsing Aggressive Non-Hodgkin's Lymphoma, run by Auxilio Mutuo Cancer Center.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The response rate of the combination of Gemcitabine-Oxaliplatin-Rituximab. (time frame: 5 years). 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 13 Jul 2012.