prednisone and Blood Diseases

prednisone has been researched along with Blood Diseases in 103 studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Research

Studies (103)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Cyclophosphamide PK: Cmax

Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Doxorubicin PK: Cmax

Cmax was determined using the post-dose Doxorubicin plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Obinutuzumab PK: Cmax

Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Percentage of Participants Who Are Alive and Without Disease Progression at Month 12

Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions. (NCT02055820)
Timeframe: Month 12

Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification

CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to NCT02055820)
Timeframe: Baseline up to end of treatment (approx. 6 months)

Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC

CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)

Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC

"Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.~CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR" (NCT02055820)
Timeframe: Baseline to end of treatment (up to approximately 6 months)

Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)

CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)

Rituximab PK: Cmax

Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Rituximab PK: Cmin Within the Dosing Interval

Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2. (NCT02055820)
Timeframe: Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)

Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)

DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs. (NCT02055820)
Timeframe: Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)

Safety: Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02055820)
Timeframe: Baseline up to approximately 36 months

Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)

"AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as hour*micrograms per milliliter (hr*mcg/mL)" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)

Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)

"Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as micrograms per milliliter" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval

Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)

Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

Vincristine PK: Cmax

Cmax was determined using the post-dose Vincristine plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Prednisone Plasma PK: AUC

AUC was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

Prednisone Plasma PK: Cmax

Cmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

Prednisone Plasma PK: Tmax

Tmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

Relative Dose Intensity of Venetoclax

Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)

Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy

Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)

18-Month Survival

18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate). (NCT00722137)
Timeframe: Up to month 18 from the time of randomization

Number of Participants Experiencing an Adverse Event (AE)

An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug. (NCT00722137)
Timeframe: Up to 107.4 months

Overall Response Rate (ORR)

ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Overall Survival (OS)

OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Overall Survival (OS) in Long Term Follow-up Period

OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Up to 107.4 months

Progression Free Survival (PFS)

PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Time to Next Anti-lymphoma Treatment (TTNT)

The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: : Median duration of follow-up of 40 months

Time to Progression (TTP)

Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Treatment-free Interval (TFI)

The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Duration of Response

The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH). (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Overall Complete Response (CR + CRu)

Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

Number of Participant Fatalities

The number of participant fatalities was evaluated throughout the study. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Demyelinating Neurological Disorders

The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Hematologic Conditions

The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Infusion-Related Reactions/Hypersensitivity

The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Lymphoproliferative Disorders/Malignancies

The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With New or Worsening Congestive Heart Failure

The number of participants with new or worsening congestive heart failure was evaluated throughout the study. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Serious Infections

The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections. (NCT00705614)
Timeframe: Up to 5 Years

Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months

The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With a Draining Fistula By Study Visit

The number of participants with a draining fistula was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Participant Assessment of Overall Health Status By Study Visit

The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status. (NCT00705614)
Timeframe: Up to 5 Years

The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit

The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes. (NCT00705614)
Timeframe: Up to 5 Years

Work/Daily Activity Status Score By Study Visit

The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning. (NCT00705614)
Timeframe: Up to 5 Years

5-year Overall Survival

Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Failure-free Survival at 5 Years

"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission." (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5

Incidence of Second Cancers

Number of patients who developed second primary cancers (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Reviews

6 reviews available for prednisone and Blood Diseases

Trials

25 trials available for prednisone and Blood Diseases

Other Studies

72 other studies available for prednisone and Blood Diseases