Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT ID: NCT01363128
Last Updated: 2021-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2011-07-12
2020-04-08
Brief Summary
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Detailed Description
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I. To evaluate the clinical efficacy of the combination of hyper-CVAD (cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone) + ofatumumab in patients with newly diagnosed acute lymphoblastic leukemia with any level of CD20 expression: event-free survival; overall response rate; overall survival.
SECONDARY OBJECTIVES:
I. To evaluate the safety of this combination.
OUTLINE:
COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide intravenously (IV) over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or orally (PO) once daily (QD) on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.
COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.
Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (hyper-CVAD, ofatumumab)
COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.
COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.
Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.
Cyclophosphamide
Given IV
Cytarabine
Given IV
Dexamethasone
Given IV or PO
Doxorubicin Hydrochloride
Given IV
Laboratory Biomarker Analysis
Correlative studies
Methotrexate
Given IV
Ofatumumab
Given IV
Vincristine Sulfate
Given IV
Interventions
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Cyclophosphamide
Given IV
Cytarabine
Given IV
Dexamethasone
Given IV or PO
Doxorubicin Hydrochloride
Given IV
Laboratory Biomarker Analysis
Correlative studies
Methotrexate
Given IV
Ofatumumab
Given IV
Vincristine Sulfate
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failure to one induction course of chemotherapy (these patients will be analyzed separately)
* Performance status of 0, 1, or 2
* Creatinine less than or equal to 3.0 mg/dL (unless considered tumor related)
* Bilirubin less than or equal to 3.0 mg/dL (unless considered tumor related)
* Adequate cardiac function defined as no clinically significant history of arrhythmia as determined by the principal investigator (PI) and/or the treating physician, history of myocardial infarction (MI) or clinically significant abnormal electrocardiogram (EKG), as determined by the PI and/or the treating physician, within 3 months prior to study enrollment; cardiac function will be assessed by history and physical examination
* No active or co-existing malignancy (other than ALL or lymphoblastic lymphoma) with life expectancy less than 12 months due to that malignancy
Exclusion Criteria
* Known to be human immunodeficiency virus positive (HIV+)
* Philadelphia chromosome (Ph)+ ALL
* Active and uncontrolled disease/infection as judged by the treating physician
* Unable or unwilling to sign the consent form
* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
* Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half-lives (calculated by multiplying the reported terminal half-life by 5) or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
* History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
* Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; consult with a physician experienced in care \& management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive
* Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case reflexively perform a HC radioimmunoblotting assay (RIBA) immunoblot assay on the same sample to confirm the result
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elias Jabbour
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
Sasaki K, Kantarjian HM, Morita K, Short NJ, Konopleva M, Jain N, Ravandi F, Garcia-Manero G, Wang S, Khoury JD, Jorgensen JL, Champlin RE, Khouri IF, Kebriaei P, Schroeder HM, Khouri M, Garris R, Takahashi K, O'Brien SM, Jabbour EJ. Hyper-CVAD plus ofatumumab versus hyper-CVAD plus rituximab as frontline therapy in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: A propensity score analysis. Cancer. 2021 Sep 15;127(18):3381-3389. doi: 10.1002/cncr.33655. Epub 2021 Jun 17.
Jabbour E, Richard-Carpentier G, Sasaki Y, Konopleva M, Patel K, Roberts K, Gu Z, Wang F, Huang X, Sasaki K, Short NJ, Jain N, Ravandi F, Daver NG, Kadia TM, Alvarado Y, DiNardo CD, Issa GC, Pemmaraju N, Garcia-Manero G, Verstovsek S, Wang S, Khoury JD, Jorgensen J, Champlin R, Khouri I, Kebriaei P, Schroeder H, Khouri M, Mullighan CG, Takahashi K, O'Brien SM, Kantarjian H. Hyper-CVAD regimen in combination with ofatumumab as frontline therapy for adults with Philadelphia chromosome-negative B-cell acute lymphoblastic leukaemia: a single-arm, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e523-e533. doi: 10.1016/S2352-3026(20)30144-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2011-01061
Identifier Type: REGISTRY
Identifier Source: secondary_id
2010-0708
Identifier Type: OTHER
Identifier Source: secondary_id
2010-0708
Identifier Type: -
Identifier Source: org_study_id
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