Non-Hodgkin's LymphomaPhase 2NCT00151281
Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
A Phase 2 study testing PEPC, Thalidomide and Rituximab in people with Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Primary Objective: Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- PEPC, Thalidomide and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to 7 Apr 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-)
- Patient has persistent / recurrent disease after standard chemotherapy
- Patient has not received either standard or investigational drugs within the last 3 weeks
- Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
- Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
- Age > 18 years
Show all 12Show fewer
- Absolute granulocyte count > 1000 cells/mm3
- Platelet count > 50,000 cells/mm3
- Creatinine < 2.0 x ULN
- Total bilirubin < 2.0 x ULN
- Patient has KPS > 50%
- Patient agrees to use birth control if of reproductive potential
Who cannot join
- Known central nervous system (CNS) involvement by lymphoma
- Known HIV disease
- Known peripheral neuropathy > grade 2
- Patient is pregnant or nursing
- Patient has had major surgery within the last 3 weeks
- Patient is receiving other investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
Primary Objective:
Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.
Read more
Secondary Objectives:
- Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
- Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
- Assess the quality of life of patients receiving RT-PEPC treatment
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- PEPC, Thalidomide, Rituximab
- Keywords
- relapsed mantle cell lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPCDrug
Also called Prednisone, Cyclophosphamide, Etoposide, Procarbazine
Induction phase (month 1-3)
- PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.
Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
- PEPC QOD or fractionated weekly basis
ThalidomideDrug
Induction phase (month 1-3)
- Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
- Daily low dose thalidomide (50-100mg/d)
RituximabDrug
Induction phase (month 1-3)
- Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.
Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
- Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment Arm | Experimental | Not described Receives: Drug: PEPC; Drug: Thalidomide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival and Progression Free Survival
measured by overall Response Rate (ORR), which includes Complete response and partial response.
Measured: 38 months
Secondary outcomes (3)
Asses the Toxicity Profiles
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
Measured: 38 months
Dynamic Levels of Plasma VEGF
Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1.
Measured: 38 months
The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.
ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below.
Measured: baseline, every 2 months until Month 6, and every 6 months until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2009
- Study completion7 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Leonard, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151281
- Sponsor's protocol ID
- 047080073974
- Status last verified
- Jun 2018
- First submitted
- 6 Sep 2005
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. doi: 10.1002/cncr.25055.
PubMed 20235190
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00151281
- Acronym / sponsor ID
- 047080073974
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- relapsed mantle cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- 7 Apr 2011 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 12 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.
Secondary Objectives:
- Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
- Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
- Assess the quality of life of patients receiving RT-PEPC treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment Arm | Experimental | Drug: PEPC, Drug: Thalidomide, Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-)
- Patient has persistent / recurrent disease after standard chemotherapy
- Patient has not received either standard or investigational drugs within the last 3 weeks
- Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
- Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
Key exclusion criteria (6 listed)
- Known central nervous system (CNS) involvement by lymphoma
- Known HIV disease
- Known peripheral neuropathy > grade 2
- Patient is pregnant or nursing
- Patient has had major surgery within the last 3 weeks
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 |
|---|---|---|
| PEPCAlso: Prednisone, Cyclophosphamide, Etoposide, ProcarbazineInduction phase (month 1-3) • PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis. Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase (post-month 12 until disease progression) • PEPC QOD or fractionated weekly basis | Drug | Study Treatment Arm |
| ThalidomideInduction phase (month 1-3) • Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day. Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase (post-month 12 until disease progression) • Daily low dose thalidomide (50-100mg/d) | Drug | Study Treatment Arm |
| RituximabInduction phase (month 1-3) • Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase (post-month 12 until disease progression) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months | Drug | Study Treatment Arm |
Primary outcome
Overall Survival and Progression Free Survival
Time frame: 38 months
measured by overall Response Rate (ORR), which includes Complete response and partial response.
3 secondary outcomes
Asses the Toxicity Profiles
Time frame: 38 months
Dynamic Levels of Plasma VEGF
Time frame: 38 months
The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
Time frame: baseline, every 2 months until Month 6, and every 6 months until disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20235190Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. doi: 10.1002/cncr.25055.
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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.
John P Leonard, MD principal investigator
Weill Medical College of Cornell University
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 PEPC, Thalidomide and Rituximab in people with Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University 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?
The sponsor lists 12 inclusion and 6 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 28 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival and Progression Free Survival (time frame: 38 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151281, which also lists 1 linked publication.
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 28 Jun 2018.