LymphomaPhase 1/2CHOP-RNCT01527422
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
A Phase 1/2 study testing Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in people with Lymphoma and Non Hodgkin's Lymphoma, run by Fernando Cabanillas at 1 site in Puerto Rico.
Trial summary
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non Hodgkin's Lymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Jan 2006to Mar 2011
- Phase
- Phase 1/2
- 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 previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
- Must have measurable or evaluable disease.
- Stage I-IV patients are eligible
- Patients must be 18 years or older.
- No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
- Written Consent
Who cannot join
- HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
- Patients with inadequate bone marrow and organ function as defined below:
- Neutrophils <1,000/l
- Platelets <100,000/l
- Billirubin >2
- Creatinine >2.0 or estimated CrCl <30 cc/min
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- CNS involvement by Lymphoma.
- Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection.
- Active infection or fever > 38.2 degrees C unless due to lymphoma.
- Subject is not using adequate contraceptive precautions.
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00919
About this study
Official title: Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.
Read the detailed description
1.1 Primary Objective:
- To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts. 1.2 Secondary Objective:
- To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique.
- Conditions
- Lymphoma, Non Hodgkin's Lymphoma
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
- Keywords
- Aggressive Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, Doxorubicin, Vincristine and PrednisoneDrug
Also called Cyclophosphamide (Cytoxan), Doxorubicin (Adryamicin), Vincristine (Oncovin), Prednisone
Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startJan 2006
- Primary completionNov 2010
- Study completionMar 2011
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernando Cabanillas
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor-investigator, Fernando Cabanillas, Auxilio Mutuo Cancer Center
- Investigators
- Fernando Cabanillas, MD, Principal investigator, AuxilioFernando Cabanillas, MD, Principal investigator, Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527422
- Sponsor's protocol ID
- NCT01297478
- Acronym
- CHOP-R
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"
- ClinicalTrials.gov ID
- NCT01527422
- Acronym / sponsor ID
- CHOP-R / NCT01297478
- Conditions
- Lymphoma, Non Hodgkin's Lymphoma
- Keywords
- Aggressive Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fernando CabanillasUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jan 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 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.
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.
Detailed description
1.1 Primary Objective:
- To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts. 1.2 Secondary Objective:
- To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (6 listed)
- Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
- Must have measurable or evaluable disease.
- Stage I-IV patients are eligible
- Patients must be 18 years or older.
- No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
Key exclusion criteria (11 listed)
- HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
- Patients with inadequate bone marrow and organ function as defined below:
- Neutrophils <1,000/l
- Platelets <100,000/l
- Billirubin >2
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 |
|---|---|---|
| Cyclophosphamide, Doxorubicin, Vincristine and PrednisoneAlso: Cyclophosphamide (Cytoxan), Doxorubicin (Adryamicin), Vincristine (Oncovin), PrednisoneRituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3. | Drug | – |
Primary outcome
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
Time frame: up to 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 Feb 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.
Fernando Cabanillas, MD principal investigator
Auxilio
Fernando Cabanillas, MD principal investigator
Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in people with Lymphoma and Non Hodgkin's Lymphoma, run by Fernando Cabanillas at 1 site in Puerto Rico.
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 6 inclusion and 11 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 Feb 2012. 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 Puerto Rico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R (time frame: up to 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 Feb 2012.