Status:
UNKNOWN
Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia
Lead Sponsor:
Asan Medical Center
Conditions:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief 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 Le...
Detailed Description
According to the recent results on the outcome of escalated daunorubicin-based protocol for adult ALL which has been performed by 'Adult ALL Working Party of the Korean Society of Hematology' (data we...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01429610
Start Date
November 1 2011
End Date
January 1 2019
Last Update
July 24 2018
Active Locations (19)
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1
Chonnam National University Hwasun Hospital
Hwasun, Chollanamdo, South Korea
2
Hematologic Oncology Clinic, National Cancer Center
Ilsan, Kongki, South Korea
3
Division of Hematology-Oncology, Dong-A University College of Medicine
Busan, South Korea
4
Dong-A University College of Medicine
Busan, South Korea