Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Cytarabine; Rituximab

Criteria

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)