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Completed

NCT Number: NCT01358253

Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

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

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

About this study

Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients.

In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission.

Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Doxorubicin

Drug

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

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.

Dexamethasone

Drug

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

Cytarabine

Drug

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

methotrexate

Drug

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

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.

6-Mercaptopurine

Drug

Maintenance:60mg/m2 daily for 24 months.

Prednisone

Drug

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

L-Asparaginase

Drug

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

Primary outcomes

  1. CR duration

    Time frame: After two 21-day courses

    Bone marrow MRD examination every two months

  2. disease free survival

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 23, 2011
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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