Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

NCT01358253 | Completed Phase 4 DMC

• 1 other identifier: RJ-2010-56
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Rituximab; HyperCVAD

Outcome Measures

Primary Outcomes (2)

• CR duration

  Bone marrow MRD examination every two months

  After two 21-day courses

• disease free survival

  2 year

Study Arms (2)

HyperCVAD

ACTIVE COMPARATOR

Consolidation: HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9.

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Cytarabine; Drug: Methotrexate; Drug: 6-Mercaptopurine; Drug: Prednisone; Drug: L-asparaginase

R-HyperCVAD

EXPERIMENTAL

Consolidation: R-HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Rituximab in month 6 and 12.

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Cytarabine; Drug: Methotrexate; Drug: Rituximab; Drug: 6-Mercaptopurine; Drug: Prednisone; Drug: L-asparaginase

Interventions

Cyclophosphamide DRUG

300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).

HyperCVAD; R-HyperCVAD

Doxorubicin DRUG

50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).

HyperCVAD; R-HyperCVAD

Vincristine DRUG

Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.

HyperCVAD; R-HyperCVAD

Dexamethasone DRUG

40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)

HyperCVAD; R-HyperCVAD

Cytarabine DRUG

2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).

HyperCVAD; R-HyperCVAD

Methotrexate DRUG

Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months.

HyperCVAD; R-HyperCVAD

Rituximab DRUG

Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times). Maintenance:375 mg/m2 IV in 6th month and 12th month.

R-HyperCVAD

6-Mercaptopurine DRUG

Maintenance:60mg/m2 daily for 24 months.

HyperCVAD; R-HyperCVAD

Prednisone DRUG

Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.

HyperCVAD; R-HyperCVAD

L-asparaginase DRUG

Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.

HyperCVAD; R-HyperCVAD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of CD20-positive ALL
• Adequate liver function (bilirubin less than or equal to 1.5\*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5\*ULN, unless considered due to tumor)
• Signed informed consent

You may not qualify if:

• Prior history of treatment with high-dose Ara-C, MTX or rituximab
• Pregnant or lactating women
• History of allergy to rituximab
• Unable to sign informed consent
• Active replication of HBV
• History of stem cell transplantation

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Dexamethasone; Cytarabine; Methotrexate; Rituximab; Mercaptopurine; Prednisone; Asparaginase

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfhydryl Compounds; Sulfur Compounds; Purines; Pregnadienediols; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Weili Zhao, MD,PhD

  Department of hematology Ruijin Hospital/Shanghai Institute of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 23, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 20, 2014

Record last verified: 2011-05

Locations

CN (1)