Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly… (NCT01854372) | Clinical Trial Compass
WithdrawnPhase 2
Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement.
0Started 2013-06
Plain-language 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 Rituximab-Methotrexate-Cytarabine, in concert with optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and close clinical follow-up.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression free survival verified by PET scan.
Timeframe: 6 weeks
Trial details
NCT IDNCT01854372
SponsorThe University of Texas Health Science Center at San Antonio
. 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
Exclusion criteria
. 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
. 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