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

NCT01429610 | Unknown Phase 2

• 1 other identifier: KALLA0804
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 19

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 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

Keywords

acute lymphoblastic leukemia; rituximab; VPDL; CD20

Outcome Measures

Primary Outcomes (1)

• relapse-free survival (RFS) rate

  2 years

Secondary Outcomes (4)

• complete remission (CR) rates

  4 weeks (from the initiation of induction treatment)

• relapse-free survival rates

  2 years

• overall survival rates

  2 years

• Cumulative incidence and maximal severity of acute / chronic graft-versus-host disease

  2 years

Study Arms (1)

Rituximab+mVPDL

EXPERIMENTAL

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

Drug: Rituximab+mVPDL

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

Also known as: Mabthera, VCS, Daunobrastina, Solondo, Leunase, Cytarabine, Efosin, DBLMethotrexate

Rituximab+mVPDL

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age and over.
• Adequate renal function (creatinine\<1.5 mg/dL)
• All patients gave written informed consent according to guidelines at each institution's committee on human research.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (19)

Chonnam National University Hwasun Hospital

Hwasun, Chollanamdo, South Korea

Location

Hematologic Oncology Clinic, National Cancer Center

Ilsan, Kongki, South Korea

Location

Division of Hematology-Oncology, Dong-A University College of Medicine

Busan, South Korea

Location

Dong-A University College of Medicine

Busan, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Inje University Haeundae-Paik Hospital

Busan, South Korea

Location

Kosin University College of Medicine, Kosin University Gospel Hospital

Busan, South Korea

Location

Catholic University of Daegu School of Medicine

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National Unviersity Hospital

Daegu, South Korea

Location

Yeungnam University College of Medicine

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Soonchunhyang University Hospital

Seoul, South Korea

Location

Ulsan University Hospital, University of Ulsan College of Medicine

Ulsan, South Korea

Location

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MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Rituximab; Asparaginase; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Young Don Joo, MD, PhD

  Inje University Haeundae Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 7, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

KR (19)