Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2013-04-29
2019-04-29
Brief Summary
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\- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.
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Detailed Description
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* Hairy cell leukemia (HCL) is an indolent B-cell leukemia comprising 2% of all leukemias, or approximately 900 of the 44,000 new cases of leukemia/year in the US
* Over the last two decades, immunotoxin research has accumulated to support a role for CD22-targeted therapy in the treatment of HCL.
* Moxetumomab pasudotox is a recombinant immunotoxin containing an Fv fragment of an anti-CD22 monoclonal antibody and truncated Pseudomonas exotoxin.
* Moxetumomab pasudotox has demonstrated a high complete response (CR) rate in patients with chemoresistant HCL and has shown activity in pediatric acute lymphoblastic leukemia as well.
* Modification of the structure of moxetumomab pasudotox has greatly improved binding and cytotoxicity toward CD22 expressing malignant cells compared to the precursor molecule. Preclinical and clinical studies have demonstrated that this increase in binding affinity results in improved antitumor activity and tolerability
* Currently there are no approved agents with significant efficacy for HCL patients after failure of standard therapy
Design:
* This is a multicenter, single-arm study of moxetumomab pasudotox in patients with relapsed/refractory hairy cell leukemia.
* 77 patients will be enrolled to receive moxetumomab pasudotox intravenously (IV) on days 1, 3 and 5 of each 28 day cycle for a maximum of 6 cycles or until disease progression, unacceptable toxicity occurs, the subject begins alternate therapy, or documented CR (for subjects who have no assessable minimal residual disease and not to exceed 6 cycles). If less than or equal to 2 of the first 25 patients do not achieve durable CR, no additional patients will be accrued.
* The overall IRB accrual ceiling is currently set at 80 to allow for a small number of patients that cannot be assessed for response.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Moxetumomab pasudotox 40 µg/kg
Patients will receive Moxetumomab Pasudotox intravenously (IV) over 30 minutes on days 1, 3, 5 of each 28 day cycle for a maximum of 6 cycles or until disease progression, unacceptable toxivity, initiation of alternate therapy or documented CR.
Moxetumomab pasudotox
IV Bag Protectant for Moxetumomab pasudotox
Interventions
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Moxetumomab pasudotox
IV Bag Protectant for Moxetumomab pasudotox
Eligibility Criteria
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Inclusion Criteria
* Patients must be Pseudomonas-immunotoxin naive
* Patients must have had at least 2 prior purine analogs, or at least 1 course of purine analog and 1 of either rituximab or BRAF inhibitor.
* Men or women age greater than or equal to 18 years.
* ECOG performance status less than or equal to 2.
* Patients must have adequate organ function
Exclusion Criteria
* Patients who are receiving any other investigational agents.
* Patients with known brain metastases should be excluded from this clinical trial
* Patients with clinically significant ophthalmologic findings during screening
* Pregnant or breastfeeding females.
* Positive for Hepatitis B core antibody or surface antigen unless the patient is on Lamivudine or Entecavir and Hepatitis B Viral DNA load is less than 2000 IU/mL.
* Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers
* HIV-positive patients unless taking appropriate anti-HIV medications with a CD4 count of greater than 200.
* History of allogeneic bone marrow transplant.
* Patients with history of both thromboembolism and known congenital hypercoagulable conditions.
* Uncontrolled pulmonary infection, pulmonary edema.
* Adequate oxygen saturation
* Radioimmunotherapy within 2 years prior to enrollment in study.
* Adequate hematologic function
* Adequate lung function
* Patients with history of thrombotic microangiopathy or thrombotic microangiopathy / hemolytic uremic syndrome
* Patients with QTc interval (Friderica) elevation \> 500 msec based on at least 2 separate 12-lead ECGs
* Patient on high dose estrogen
* Patients with clinical evidence of disseminated intravascular coagulation
18 Years
100 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Duarte, California, United States
Research Site
Los Angeles, California, United States
Research Site
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Bethesda, Maryland, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
New York, New York, United States
Research Site
Houston, Texas, United States
Research Site
Antwerp, , Belgium
Research Site
Ghent, , Belgium
Research Site
Edmonton, Alberta, Canada
Research Site
Brno, , Czechia
Research Site
Caen, , France
Research Site
Le Chesnay, , France
Research Site
Pessac, , France
Research Site
Pierre-Bénite, , France
Research Site
Rouen, , France
Research Site
Strasbourg, , France
Research Site
Berlin, , Germany
Research Site
Giessen, , Germany
Research Site
Heidelberg, , Germany
Research Site
Dublin, , Ireland
Research Site
Haifa, , Israel
Research Site
Bologna, , Italy
Research Site
Genova, , Italy
Research Site
Milan, , Italy
Research Site
Siena, , Italy
Research Site
Bergen, , Norway
Research Site
Gdansk, , Poland
Research Site
Lodz, , Poland
Research Site
Belgrade, , Serbia
Research Site
Barcelona, , Spain
Research Site
Sutton, , United Kingdom
Countries
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References
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Bouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12.
Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.
Sharpe RW, Bethel KJ. Hairy cell leukemia: diagnostic pathology. Hematol Oncol Clin North Am. 2006 Oct;20(5):1023-49. doi: 10.1016/j.hoc.2006.06.010.
Kreitman RJ, Tallman MS, Robak T, Coutre S, Wilson WH, Stetler-Stevenson M, Fitzgerald DJ, Lechleider R, Pastan I. Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia. J Clin Oncol. 2012 May 20;30(15):1822-8. doi: 10.1200/JCO.2011.38.1756. Epub 2012 Feb 21.
Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Karlin L, Robak T, Gladstone DE, le Coutre P, Dietrich S, Gotic M, Larratt L, Offner F, Schiller G, Swords R, Bacon L, Bocchia M, Bouabdallah K, Breems DA, Cortelezzi A, Dinner S, Doubek M, Gjertsen BT, Gobbi M, Hellmann A, Lepretre S, Maloisel F, Ravandi F, Rousselot P, Rummel M, Siddiqi T, Tadmor T, Troussard X, Yi CA, Saglio G, Roboz GJ, Balic K, Standifer N, He P, Marshall S, Wilson W, Pastan I, Yao NS, Giles F. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018 Aug;32(8):1768-1777. doi: 10.1038/s41375-018-0210-1. Epub 2018 Jul 20.
Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Robak T, le Coutre PD, Gjertsen BT, Troussard X, Roboz GJ, Karlin L, Gladstone DE, Kuptsova-Clarkson N, Liu S, Patel P, Rotolo F, Mitry E, Pastan I, Giles F; Study 1053 investigators. Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial. J Hematol Oncol. 2021 Feb 24;14(1):35. doi: 10.1186/s13045-020-01004-y.
Abou Dalle I, Ravandi F. Moxetumomab pasudotox for the treatment of relapsed and/or refractory hairy cell leukemia. Expert Rev Hematol. 2019 Sep;12(9):707-714. doi: 10.1080/17474086.2019.1643231. Epub 2019 Aug 1.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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NIH Clinical Center Detailed Web Page
130106\_(CD-ON-CAT-8015-1053)\_current\_SAP\_redacted\_PDF-A
Protocol-cd-on-cat-8015-1053-amendment-9\_redacted\_PDF-A
Other Identifiers
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13-C-0106
Identifier Type: OTHER
Identifier Source: secondary_id
CD-ON-CAT-8015-1053
Identifier Type: OTHER
Identifier Source: secondary_id
130106
Identifier Type: -
Identifier Source: org_study_id
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