Non-Hodgkin's LymphomaPhase 2NCT00276003
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
A Phase 2 study testing Gemcitabine, Irinotecan, Allopurinol. in people with Non-Hodgkin's Lymphoma and Cancer, run by University of New Mexico at 2 sites in United States.
Trial summary
Primary objectives Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan. Secondary objectives Assess progression free survival in these patients treated with this regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Cancer
- What is being tested?
- Gemcitabine, Irinotecan, Allopurinol.
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2002to Aug 2005
- 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 a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.
- Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.
- Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.
- The patient must have bidimensionally measurable or evaluable disease.
- Age > 18 years.
- ECOG Performance status < 2
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- Informed consent.
- ANC > 1.5, platelet count > 100K, creatinine< 2.0, bilirubin < 3
- Female patients must have a negative pregnancy test.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, 87108
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Primary objectives
- Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
Secondary objectives
- Assess progression free survival in these patients treated with this regimen.
- Assess toxicity of this regimen in this group of patients.
Read the detailed description
The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.
- Conditions
- Non-Hodgkin's Lymphoma, Cancer
- Being tested
- Gemcitabine, Irinotecan, Allopurinol.
- Keywords
- Lymphoma-Non Hodgkins, Phase II, Gemcitabine, Irinotecan
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Irinotecan, Allopurinol.Drug
Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
Measured: 3 years
Secondary outcomes (2)
Assess progression free survival in these patients with this regimen.
Measured: 3 years
Assess toxicity of this regimen in this group of patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startAug 2002
- Primary completionJun 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Ian Rabinowitz, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276003
- Sponsor's protocol ID
- 0101C
- Status last verified
- Dec 2009
- First submitted
- 11 Jan 2006
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
- ClinicalTrials.gov ID
- NCT00276003
- Acronym / sponsor ID
- 0101C
- Conditions
- Non-Hodgkin's Lymphoma, Cancer
- Keywords
- Lymphoma-Non Hodgkins, Phase II, Gemcitabine, Irinotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Jan 2006 (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.
Primary objectives
- Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
Secondary objectives
- Assess progression free survival in these patients treated with this regimen.
- Assess toxicity of this regimen in this group of patients.
Detailed description
The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.
- Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.
- Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.
- The patient must have bidimensionally measurable or evaluable disease.
- Age > 18 years.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gemcitabine, Irinotecan, Allopurinol.Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle | Drug | – |
Primary outcome
Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
Time frame: 3 years
2 secondary outcomes
Assess progression free survival in these patients with this regimen.
Time frame: 3 years
Assess toxicity of this regimen in this group of patients.
Time frame: 3 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 7 Jan 2010.
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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.
Ian Rabinowitz, MD principal investigator
University of New Mexico
2 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 Gemcitabine, Irinotecan, Allopurinol. in people with Non-Hodgkin's Lymphoma and Cancer, run by University of New Mexico at 2 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 9 inclusion and 0 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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan. (time frame: 3 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 7 Jan 2010.