Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial
— RADICALOfficial title:
Phase 2 Study Evaluating the Efficacy of Rituximab Plus Modified VPDL for Newly Diagnosed CD20-Positive Adult Acute Lymphoblastic Leukemia
Verified date | July 2018 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 78 |
Est. completion date | January 1, 2019 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility |
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 - 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Hematology-Oncology, Dong-A University College of Medicine | Busan | |
Korea, Republic of | Dong-A University College of Medicine | Busan | |
Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Inje University Haeundae-Paik Hospital | Busan | |
Korea, Republic of | Kosin University College of Medicine, Kosin University Gospel Hospital | Busan | |
Korea, Republic of | Catholic University of Daegu School of Medicine | Daegu | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | Kyungpook National Unviersity Hospital | Daegu | |
Korea, Republic of | Yeungnam University College of Medicine | Daegu | |
Korea, Republic of | Chungnam National University Hospital | Daejeon | |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | Chollanamdo |
Korea, Republic of | Hematologic Oncology Clinic, National Cancer Center | Ilsan | Kongki |
Korea, Republic of | Asan Medical Center, University of Ulsan College of Medicine | Seoul | |
Korea, Republic of | Chung-Ang University Hospital | Seoul | |
Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Soonchunhyang University Hospital | Seoul | |
Korea, Republic of | Ulsan University Hospital, University of Ulsan College of Medicine | Ulsan |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relapse-free survival (RFS) rate | 2 years | ||
Secondary | complete remission (CR) rates | among total patients / each subset of subsets A. [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age=60 years) Risk group: standard vs. high |
4 weeks (from the initiation of induction treatment) | |
Secondary | relapse-free survival rates | among patients in each subset of A & B. [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age=60 years) Risk group: standard vs. high. [Subset B] AlloHCT recipients vs. non-recipients. |
2 years | |
Secondary | overall survival rates | among total patients / each subset of A & B [Subset A] Precursor B-cell vs. T-cell Younger (age<60 years) vs. older (age=60 years) Risk group: standard vs. high [Subset B] AlloHCT recipients vs. non-recipients. |
2 years | |
Secondary | Cumulative incidence and maximal severity of acute / chronic graft-versus-host disease | among alloHCT recipients | 2 years |
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