Trial record 1 of 2 for:
Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma | Romania
Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01909934 |
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Recruitment Status :
Active, not recruiting
First Posted : July 29, 2013
Results First Posted : May 26, 2022
Last Update Posted : May 26, 2022
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Sponsor:
Takeda
Collaborator:
Takeda Development Center Americas, Inc.
Information provided by (Responsible Party):
Takeda
- Study Details
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Brief Summary:
This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in participants with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anaplastic Large-cell Lymphoma | Drug: brentuximab vedotin | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma |
| Actual Study Start Date : | January 30, 2014 |
| Actual Primary Completion Date : | May 4, 2021 |
| Estimated Study Completion Date : | October 4, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Brentuximab vedotin
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brentuximab vedotin
1.8 mg/kg IV infusion
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Drug: brentuximab vedotin
Brentuximab vedotin will be administered as a single intravenous (IV) infusion over 30 minutes on Day 1 of each 3 week cycle for up to a maximum of 16 cycles and should be administered for a minimum of 8 cycles for participants who achieve stable disease or better.
Other Names:
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Primary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years) ]ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Secondary Outcome Measures :
- Duration of Response (DOR) as Per IRF [ Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) ]DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than SCT, or discontinued treatment due to undocumented PD after the last adequate disease assessment.
- Progression-free Survival (PFS) as Per IRF [ Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) ]PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility.
- Complete Remission Rate (CRR) [ Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) ]CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.
- Overall Survival (OS) [ Time Frame: Until death or the data cut-off date: 4 May 2021 (Up to approximately 7 years) ]OS is defined as the time from start of study treatment to date of death due to any cause.
- Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin [ Time Frame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) ]
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events, Related Adverse Events and Adverse Events by Severity (Grade 3 or Higher) [ Time Frame: From first dose up to 30 days post last dose of study drug (Up to approximately 17 months) ]An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. Serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.
- Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion [ Time Frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion ]
- Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody [ Time Frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion ]
- Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) [ Time Frame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion ]
- Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antidrug Antibody (Nab) to Brentuximab Vedotin [ Time Frame: Up to 16 cycles (each cycle = 21 days) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
- Bidimensional measurable disease
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
- Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
- Clinical laboratory values as specified in the study protocol
Exclusion Criteria:
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).
- Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- Female participants who are lactating and breastfeeding or pregnant
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909934
Locations
Show 40 study locations
Sponsors and Collaborators
Takeda
Takeda Development Center Americas, Inc.
Investigators
| Study Director: | Study Director | Takeda |
Study Documents (Full-Text)
Documents provided by Takeda:
Documents provided by Takeda:
Study Protocol [PDF] August 27, 2021
Statistical Analysis Plan [PDF] June 18, 2021
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT01909934 |
| Other Study ID Numbers: |
C25006 2012-004128-39 ( EudraCT Number ) U1111-1154-9784 ( Registry Identifier: WHO ) REec-2014-0649 ( Registry Identifier: REec ) 13/NI/0072 ( Registry Identifier: NRES ) |
| First Posted: | July 29, 2013 Key Record Dates |
| Results First Posted: | May 26, 2022 |
| Last Update Posted: | May 26, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Access Criteria: | IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. |
| URL: | https://vivli.org/ourmember/takeda/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takeda:
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Lymphoma Anaplastic Large-cell Relapsed Refractory Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic monomethyl auristatin E |
Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Drug Therapy Immunotherapy Hematologic Diseases |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Brentuximab Vedotin Antineoplastic Agents, Immunological Antineoplastic Agents |