Newly Diagnosed Diffuse Large B-Cell LymphomaPhase 2NCT01854372
Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement.
A Phase 2 study testing R-HCVAD and R-MC in people with Newly Diagnosed Diffuse Large B-Cell Lymphoma and Intermediate (Burkitt-Like) Lymphoma, run by The University of Texas Health Science Center at San Antonio.
Trial summary
To estimate the I-year progression-free survival probability in patients up to 70 years of age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with alternating cycles of Rituximab-HCV AD and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Newly Diagnosed Diffuse Large B-Cell Lymphoma, Intermediate (Burkitt-Like) Lymphoma
- What is being tested?
- R-HCVAD and R-MC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Nov 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diffuse large B-cell lymphoma or intermediate ("Burkitt-like") lymphoma, newly diagnosed from an excisional biopsy or from a large core biopsy with sufficient diagnostic material to perform genetic testing for MYC-R.
- Positivity for MYC-R by Fluorescent in-situ Hybridization (FISH) or by classical cytogenetics.
- No prior lymphoma treatment, with one exception: One cycle of R-CHOP regimen is permitted (consisting of one single dose each of Rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of Prednisone when part of chemotherapy).
- No prior radiation therapy is permitted
- Age ≥ 18 years to 70 years of age
- CT imaging of neck, chest, abdomen and pelvis within 28 days prior to registration. Any additional imaging used to assess extent of disease must also have been done within 28 days prior to registration
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- Bidimensionally measurable disease by imaging within 28 days prior to registration
- Adequate bone marrow biopsy, and aspiration performed for staging within 28 days before registration, and before start of any treatment
- Indication for primary treatment with systemic multiagent chemotherapy
- Creatinine ≤ 2.0 mg/dL and estimated (Cockroft-Gault) creatinine clearance> 50 ml/min within 7 days prior to registration
- Cardiac ejection fraction of ≥ 50% by MUGA scan or by 2-D echocardiogram , as well as EKG without significant abnormality within 28 days prior to registration
- Performance status of 0, of 1, or of 2 (ECOG scale)
- Patient willing to have, and to maintain, a central venous line throughout the treatment phase (either PICC line, or double lumen tunnelled catheter, or double lumen subcutaneous venous port system)
- Willing and logistically able to be followed as outpatient at least twice weekly, during the treatment phase.
- Signed informed consent to accept transfusion of blood products as medically indicated
- Signed informed consent to participate in this trial
Who cannot join
- Age > 70 years
- Leukemic presentation, or no evidence of disease by imaging
- Unwilling to be screened for HIV. HIV positive patients must receive combined antiretroviral treatment while on study. They are excluded from participation unless they show a CD4 count >250/uL and a viral load < 50 within 28 days of registration.
- Hepatic involvement and total serum bilirubin ≥ 5 mg/dL within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dL without hepatic involvement within 7 days prior to registration
- Patients with bone marrow involvement and either ANC < 1000/uLor Platelets < 50,000/uL, within 7 days before registration
- Patients without bone marrow involvement by lymphoma, and either ANC < 1500/uL or Platelets < 100,000/uL within 7 days before registration
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- Patients with myelodysplastic syndrome, with sickle cell disease, or with transfusion dependence for over 6 months antedating the diagnosis oflymphoma.
- Known hypersensitivity to E. coli derived proteins
- Patients at risk of reactivation of hepatitis B who are unwilling to be treated with appropriate antivirals as medically indicated.
- Pregnant or nursing women, or any patient with reproductive potential and unwilling to use effective contraceptive method from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence.
- Additional or prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ~ 5 years
- Unwilling to receive transfusions of blood products as medically indicated
About this study
Official title: Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement. A Phase 2, Multi-Center, Open Label Study (CTRC# 11-53)
To estimate the I-year progression-free survival probability in patients up to 70 years of age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with alternating cycles of Rituximab-HCV AD and Rituximab-Methotrexate-Cytarabine, in concert with optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and close clinical follow-up.
- Being tested
- R-HCVAD and R-MC
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-HCVAD and R-MCDrug
| Study group | Role | What they receive |
|---|---|---|
| R-HCVAD and R-MC Chemotherapy | Experimental | R-HCVAD - Rituximab (375 mg/m2), Cyclophosphamide (300 mg/m2), Mesna (600 mg/m2), Doxorubicin (50 mg/m2), Vincristine (2 mg total), Dexamethasone (40 mg total), Methotrexate (12 mg), Cytarabine (100mg).
R-MC -Rituximab (375 mg/m2),Methotrexate (200 mg/m2 - 800mg/m2), Cytarabine (3000mg/m2), Leucovorin (15mg - 50mg). Receives: Drug: R-HCVAD and R-MC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival verified by PET scan.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854372
- Sponsor's protocol ID
- CTRC 11-53
- Status last verified
- Dec 2013
- First submitted
- 10 May 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement. A Phase 2, Multi-Center, Open Label Study (CTRC# 11-53)
- ClinicalTrials.gov ID
- NCT01854372
- Acronym / sponsor ID
- CTRC 11-53
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 May 2013 (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.
To estimate the I-year progression-free survival probability in patients up to 70 years of age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with alternating cycles of Rituximab-HCV AD and Rituximab-Methotrexate-Cytarabine, in concert with optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and close clinical follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-HCVAD and R-MC Chemotherapy | Experimental | Drug: R-HCVAD and R-MCR-HCVAD - Rituximab (375 mg/m2), Cyclophosphamide (300 mg/m2), Mesna (600 mg/m2), Doxorubicin (50 mg/m2), Vincristine (2 mg total), Dexamethasone (40 mg total), Methotrexate (12 mg), Cytarabine (100mg). R-MC -Rituximab (375 mg/m2),Methotrexate (200 mg/m2 - 800mg/m2), Cytarabine (3000mg/m2), Leucovorin (15mg - 50mg). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diffuse large B-cell lymphoma or intermediate ("Burkitt-like") lymphoma, newly diagnosed from an excisional biopsy or from a large core biopsy with sufficient diagnostic material to perform genetic testing for MYC-R.
- Positivity for MYC-R by Fluorescent in-situ Hybridization (FISH) or by classical cytogenetics.
- No prior lymphoma treatment, with one exception: One cycle of R-CHOP regimen is permitted (consisting of one single dose each of Rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of Prednisone when part of chemotherapy).
- No prior radiation therapy is permitted
- Age ≥ 18 years to 70 years of age
Key exclusion criteria (12 listed)
- Age > 70 years
- Leukemic presentation, or no evidence of disease by imaging
- Unwilling to be screened for HIV. HIV positive patients must receive combined antiretroviral treatment while on study. They are excluded from participation unless they show a CD4 count >250/uL and a viral load < 50 within 28 days of registration.
- Hepatic involvement and total serum bilirubin ≥ 5 mg/dL within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dL without hepatic involvement within 7 days prior to registration
- Patients with bone marrow involvement and either ANC < 1000/uLor Platelets < 50,000/uL, within 7 days before registration
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 |
|---|---|---|
| R-HCVAD and R-MC | Drug | R-HCVAD and R-MC Chemotherapy |
Primary outcome
Progression free survival verified by PET scan.
Time frame: 6 weeks
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 10 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-HCVAD and R-MC in people with Newly Diagnosed Diffuse Large B-Cell Lymphoma and Intermediate (Burkitt-Like) Lymphoma, run by The University of Texas Health Science Center at San Antonio.
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 16 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Progression free survival verified by PET scan. (time frame: 6 weeks). 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 Dec 2013.