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

NCT01429610 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-07-24

No results posted yet for this study

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.

Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DRUG

Rituximab+mVPDL

1. Induction: * Dauno 90 mg/m2/d by civ (d1-3) * Vinc 2 mg iv (d1, 8) * Pred 60 mg/m2/d po (d1-14) * for Ph(-): L-asp 4,000 units/m2/day im/sc (d17-28) for Ph(+): Imatinib 600mg/d po qd (d8-continue till the end of maintenance or just before alloHCT) * Rituximab 375mg/m2/d (d8) 2. Consolidation A (cycle1) * D 45 mg/m2/day by continuous iv (d1, 2) * V 2 mg iv (d1, 8) * P 60 mg/m2/day po (d1-14) * for Ph(-): L-asp (d1-14) for Ph(+): Imatinib * Rituximab 375mg/m2/d (d8) 3. Consolidation B (cycles2\&4) * Cyt 2,000 mg/m2/d iv over 2 hr (d1-4) * Eto 150 mg/m2/d iv over 3 hr (d1-4) * Rituximab 375mg/m2/d d8 4. Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hr (d1-2, 15-16) * Leucovorin 50 mg/m2 iv every 6hr for 3 doses, * Rituximab 375mg/m2/d (d8\&22) 5. Maintenance (for 2 years) \- for Ph(-): 6- Mercaptopurine 60 mg/m2 po qd Methotrexate 20 mg/m2 po qw for Ph(+): imatinib 600mg/d po qd 6. Consider alloHCT

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Young Don Joo, MD, PhD · Inje University Haeundae Paik Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2018-01-01
Completion
2019-01-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429610 on ClinicalTrials.gov