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

Sponsor
Asan Medical Center
Study ID
NCT01429610
Phase
PHASE2
Status
Unknown

Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab+mVPDL — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Jul 2018
Primary completion
Jan 1, 2018
Completion
Jan 1, 2019

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab+mVPDL
    Patients who were CD20(+), newly-diagnosed adult ALL and treated with rituximab + mVPDL treatment plan

Primary Outcome Measure

relapse-free survival (RFS) rate [ Time Frame: 2 years ]

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