Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia
South Korea78 participantsStarted 2011-11
Plain-language summary
The investigators would like to propose a phase-2 prospective multicenter trial evaluating the efficacy of rituximab combination with our current chemotherapy strategy for adult Acute Lymphoblastic Leukemia (ALL), in order to prove out whether the addition of rituximab during induction, consolidation, and post-alloHCT status can improve the outcome in terms of relapse-free survival (RFS) when compared with our prior data as a historical control.
Who can participate
Age range
15 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:
* Patients who were previously untreated and had either ALL or high-risk lymphoblastic lymphoma.
* Patients whose leukemic blast cells express ≥20% of CD20 antigens at time of diagnosis
* No prior chemotherapy for leukemia (use of hydroxyurea or leukapheresis are permitted.)
* Estimated life expectancy of more than 3 months
* ECOG performance status of 2 or lower, Karnofsky scale \> 60
* Adequate cardiac function (EF\>45%) on echocardiogram or Heart scan (MUGA scan)
* 15 years of age and over.
* Adequate renal function (creatinine\<1.5 mg/dL)
* Adequate hepatic function. (Bilirubin\<1.5 mg/dL, transaminases levels\<3 times the upper normal limit \[5 times for patients with liver metastasis or hepatomegaly\]). Even the initial level exceed the upper limits, patient will be acceptable when the levels on day 8 satisfies the inclusion criteria.
* All patients gave written informed consent according to guidelines at each institution's committee on human research.
Exclusion Criteria:
* Acute biphenotypic leukemia, acute biclonal leukemia, or acute mixed leukemia
* Presence of significant uncontrolled active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Patie…
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.