LymphomaPhase 2NCT00881387
Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
A Phase 2 study testing rituximab, gemcitabine hydrochloride and vinorelbine ditartrate in people with Lymphoma, run by University of Miami at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, gemcitabine hydrochloride and vinorelbine ditartrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2012
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types:
- Nodular sclerosis
- Mixed cellularity
- Lymphocyte-rich
- Lymphocyte-depleted
- Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy
- No known CNS metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- ANC > 1,500/mm^3
- Platelet count > 75,000/mm^3
- Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active hepatitis B infection
- No known chronic hepatitis B carrier
- No HIV positivity
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic neurological illness
- Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Significant pulmonary disease or hypoxia
- Psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered
- No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab
- No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
About this study
Official title: A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.
Read the detailed description
OBJECTIVES:
Primary
- Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine ditartrate.
Secondary
- Assess progression-free survival, failure-free survival, and overall survival of patients treated with this regimen.
- Characterize the safety profile of this regimen in these patients.
- Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in patients eligible for stem cell transplantation.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT).
- Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
- Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for at least 2 years.
- Conditions
- Lymphoma
- Being tested
- rituximab, gemcitabine hydrochloride, vinorelbine ditartrate
- Keywords
- recurrent adult Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Given IV
Given IV
vinorelbine ditartrateDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (eligible for SCT) | Experimental | Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT. Receives: Biological: rituximab; Drug: gemcitabine hydrochloride; Drug: vinorelbine ditartrate |
| Group 2 (ineligible for SCT) | Experimental | Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity. Receives: Biological: rituximab; Drug: gemcitabine hydrochloride; Drug: vinorelbine ditartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (complete response, unconfirmed complete response, partial response)
Measured: After first 3 cycles of treatment
Secondary outcomes (3)
Progression-free survival, failure-free survival, and overall survival
Measured: Treatment start date to date of death for any reason
Safety profile
Measured: Cycle 1 Day 1 through Follow-up
Rate of adequate stem cell collection
This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy
Measured: After completion of 3 cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Stefanovic, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881387
- Sponsor's protocol ID
- 20080919
- Other IDs
- SCCC-2007092
- Status last verified
- Dec 2016
- First submitted
- 14 Apr 2009
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00881387
- Acronym / sponsor ID
- 20080919
- Conditions
- Lymphoma
- Keywords
- recurrent adult Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma, adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Apr 2009 (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.
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.
Detailed description
OBJECTIVES:
Primary
- Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine ditartrate.
Secondary
- Assess progression-free survival, failure-free survival, and overall survival of patients treated with this regimen.
- Characterize the safety profile of this regimen in these patients.
- Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in patients eligible for stem cell transplantation.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT).
- Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
- Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for at least 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (eligible for SCT) | Experimental | Biological: rituximab, Drug: gemcitabine hydrochloride, Drug: vinorelbine ditartratePatients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT. |
| Group 2 (ineligible for SCT) | Experimental | Biological: rituximab, Drug: gemcitabine hydrochloride, Drug: vinorelbine ditartratePatients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| rituximabGiven IV | Biological | Group 1 (eligible for SCT), Group 2 (ineligible for SCT) |
| gemcitabine hydrochlorideGiven IV | Drug | Group 1 (eligible for SCT), Group 2 (ineligible for SCT) |
| vinorelbine ditartrateGiven IV | Drug | Group 1 (eligible for SCT), Group 2 (ineligible for SCT) |
Primary outcome
Response rate (complete response, unconfirmed complete response, partial response)
Time frame: After first 3 cycles of treatment
3 secondary outcomes
Progression-free survival, failure-free survival, and overall survival
Time frame: Treatment start date to date of death for any reason
Safety profile
Time frame: Cycle 1 Day 1 through Follow-up
Rate of adequate stem cell collection
Time frame: After completion of 3 cycle of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
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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.
Alexandra Stefanovic, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
1 site 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, gemcitabine hydrochloride and vinorelbine ditartrate in people with Lymphoma, run by University of Miami at 1 site 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?
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: withdrawn, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Response rate (complete response, unconfirmed complete response, partial response) (time frame: After first 3 cycles of treatment). 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 15 Dec 2016.