mitoxantrone and Lymphoma, Follicular

mitoxantrone has been researched along with Lymphoma, Follicular in 65 studies

Mitoxantrone: An anthracenedione-derived antineoplastic agent.
mitoxantrone : A dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8.

Lymphoma, Follicular: Malignant lymphoma in which the lymphomatous cells are clustered into identifiable nodules within the LYMPH NODES. The nodules resemble to some extent the GERMINAL CENTER of lymph node follicles and most likely represent neoplastic proliferation of lymph node-derived follicular center B-LYMPHOCYTES.

Research

Studies (65)

Authors

Clinical Trials (15)

Trial Overview

Trial Outcomes

Response Rate

"The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL~Complete Remission (CR):~Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved~Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD~Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD~Progressive Disease (PD):~SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion" (NCT01133158)
Timeframe: 7 years

Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.

(NCT01133158)
Timeframe: 7 years

Overall Survival (OS) From Randomization - Percentage of Participants With Death

OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method. (NCT01144364)
Timeframe: 12, 24, and 34 months

Percentage of Participants With Disease Progression or Death

PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date. (NCT01144364)
Timeframe: 12, 24, and 34 months

Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months

DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method. (NCT01144364)
Timeframe: 12, 24, and 36 months

Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months

Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method. (NCT01144364)
Timeframe: Months 12, 24, and 34

Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months

DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL. (NCT01144364)
Timeframe: Months 12, 24, and 34

OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months

OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method. (NCT01144364)
Timeframe: 12, 24, and 36 months

Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months

OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method. (NCT01144364)
Timeframe: 12, 24, and 34 months

Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months

PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method. (NCT01144364)
Timeframe: 12, 24, and 36 months

Percentage of Participants With a Molecular Response in the Induction Phase

Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment. (NCT01144364)
Timeframe: Months 5 and 8

Percentage of Participants With a Response During the Induction Phase

Participants without a response assessment (due to any reasons) were considered as non-responders. (NCT01144364)
Timeframe: Months 1 to 8

PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months

PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods. (NCT01144364)
Timeframe: 12, 24, and 34 months

Count of Participants With Serious and Non-Serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00114738)
Timeframe: Date treatment consent signed to date off study, approximately 143 months and 7 days

Median Overall Survival (OS)

Overall Survival is the time between the first day of treatment to the day of death. The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test. (NCT00114738)
Timeframe: up to 9.9 years

Overall Progression Free Survival

Time interval from start of treatment to documented evidence of disease progression. Progression is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes, appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, appearance of new palpable hepatomegaly or splenomegaly that was not previously present, and ≥50% increase in the absolute number of circulating lymphocytes. (NCT00114738)
Timeframe: up to 9.9 years

Overall Survival

Overall Survival is the time between the first day of treatment to the day of death. The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test. (NCT00114738)
Timeframe: up to 9.9 years

Progression Free Survival (PFS)

Time interval from start of treatment to documented evidence of disease progression. Progression is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes, appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, appearance of new palpable hepatomegaly or splenomegaly that was not previously present, and ≥50% increase in the absolute number of circulating lymphocytes.The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test. (NCT00114738)
Timeframe: up to 5 years

Clinical Response

Clinical response is assessed by the response criteria for lymphomas and is defined as a fraction of patients who have a complete response (CR) or a complete response (CR) + partial response (PR). A complete response is disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g. lactate dehydrogenase) definitely assignable to the lymphoma. Partial response is ≥50% decreased in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen, ≥50% increase in the absolute number of circulating lymphocytes. (NCT00114738)
Timeframe: up to 22 weeks after initiation of therapy

Duration of Response

Defined as the time from date of first documented confirmed response to date of disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who begin further anticancer therapy prior to disease progression will be censored at the date of last tumor assessment prior to the start date of the anticancer therapy. (NCT01626352)
Timeframe: After cycles 3 and 6 of each 21-day cycle and every 3 months thereafter until disease progression or relapse from complete response for up to 38 months

Number of Patients With a Complete Response

Disease response assessments will be performed using the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires a disappearance of all evidence of disease. (NCT01626352)
Timeframe: 18 months

Number of Patients With Treatment-Related Adverse Events (AEs) as a Measure of Safety

A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. (NCT01626352)
Timeframe: after cycles 3 and 6 of each 21-day cycle, and up to 30 days after last dose, projected 24 weeks

Overall Response (OR)

Overall response is the number of patients with observed complete or partial response (CR or PR) as assessed using the International Working Group (IMW) revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites. (NCT01626352)
Timeframe: after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter, projected 18 months

Overall Survival (OS)

Defined as the time from Day 1 of study drug administration to date of death from any cause. (NCT01626352)
Timeframe: every 3 cycles during treatment and every 3 months thereafter until progression or death from any cause, projected 18 months

Progression-free Survival

Defined as the time from first treatment until objective tumor progression, relapse from complete response, or death from any cause. Tumor response is defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. (NCT01626352)
Timeframe: After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months

Time to Progression (TTP)

Defined as the time from date of first treatment to the date of first documented disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. (NCT01626352)
Timeframe: After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months

Reviews

8 reviews available for mitoxantrone and Lymphoma, Follicular

Trials

39 trials available for mitoxantrone and Lymphoma, Follicular

Other Studies

19 other studies available for mitoxantrone and Lymphoma, Follicular