Diffuse Large B Cell LymphomaPhase 1/2NCT01004991
Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
A Phase 1/2 study testing rituximab, cyclophosphamide and vincristine in people with Diffuse Large B Cell Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- rituximab, cyclophosphamide and vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2016
- Phase
- Phase 1/2
- 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
- Patients must have histologically confirmed DLBCL with characteristic immunophenotypic profiles. Tumor tissue must be confirmed to express the CD20 antigen by flow cytometry or immunohistochemistry.
- Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
- Patient has not had any previous treatment.
- Stage II (not appropriate for abbreviated chemoimmunotherapy and radiotherapy), III or IV disease
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients must have laboratory test results within these ranges:
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- Absolute neutrophil count > = 1500/mm³
- Platelet count > = 75,000/mm³
- Serum creatinine < = 1.5X upper limit of normal (ULN)
- Total bilirubin < = 1.5X ULN. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
- AST (SGOT) and ALT (SGPT) < = 2 x ULN
- Disease free of prior malignancies for > = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
- Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine. The effects of azacytidine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Age >18 years.
- Ability to understand and the willingness to sign a written informed consent document.
- ECOG performance status of 0-2
Who cannot join
- Patients must not have any serious medical condition, laboratory abnormality,or psychiatric illness that would prevent the subject from signing the informed consent form.
- Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis B.
- Known central nervous system involvement by lymphoma.
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- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients must not have advanced malignant hepatic tumors.
- Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
375 mg/m2 on Day 8 of each of 6 cycles
cyclophosphamideDrug
750 mg/m2 on Day 8 of each of 6 cycles
vincristineDrug
1.4 mg/m2 on Day 8 of each of 6 cycles
doxorubicinDrug
50 mg/m2 on Day 8 of each of 6 cycles
prednisoneDrug
100 mg PO days 8-12 of each of 6 cycles
azacytidineDrug
Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: vincristine; Drug: doxorubicin; Drug: prednisone; Drug: azacytidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Complete Response
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionFeb 2016
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.
- Other trials for Diffuse Large B Cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Peter Martin, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004991
- Sponsor's protocol ID
- 0907010513
- Status last verified
- Feb 2017
- First submitted
- 29 Oct 2009
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01004991
- Acronym / sponsor ID
- 0907010513
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Jan 2010 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Biological: rituximab, Drug: cyclophosphamide, Drug: vincristine, Drug: doxorubicin, Drug: prednisone, Drug: azacytidinesubjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically confirmed DLBCL with characteristic immunophenotypic profiles. Tumor tissue must be confirmed to express the CD20 antigen by flow cytometry or immunohistochemistry.
- Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
- Patient has not had any previous treatment.
- Stage II (not appropriate for abbreviated chemoimmunotherapy and radiotherapy), III or IV disease
- Able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (9 listed)
- Patients must not have any serious medical condition, laboratory abnormality,or psychiatric illness that would prevent the subject from signing the informed consent form.
- Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis B.
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 |
|---|---|---|
| rituximab375 mg/m2 on Day 8 of each of 6 cycles | Biological | All patients |
| cyclophosphamide750 mg/m2 on Day 8 of each of 6 cycles | Drug | All patients |
| vincristine1.4 mg/m2 on Day 8 of each of 6 cycles | Drug | All patients |
| doxorubicin50 mg/m2 on Day 8 of each of 6 cycles | Drug | All patients |
| prednisone100 mg PO days 8-12 of each of 6 cycles | Drug | All patients |
| azacytidineDose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5 | Drug | All patients |
Primary outcome
Complete Response
Time frame: 13 months
Complete Response
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Martin, 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 1/2 study testing rituximab, cyclophosphamide and vincristine in people with Diffuse Large B Cell 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 17 inclusion and 9 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 10 Apr 2017. 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 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?
Yes. Results are posted in the registry (first posted 10 Apr 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?
Complete Response (time frame: 13 months). 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 10 Apr 2017.