Created at Source Raw Value Validated value
Nov. 18, 2022, 4 a.m. usa

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. this arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with cll that is actively progressing. v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl, mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must currently not be receiving active treatment (treatment na(sqrroot) ve or previously treated) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. this arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with cll that is actively progressing. v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl, mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must currently not be receiving active treatment (treatment na(sqrroot) ve or previously treated) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

July 15, 2022, 2:30 a.m. usa

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl, mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must currently not be receiving active treatment (treatment na(sqrroot) ve or previously treated) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl, mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must currently not be receiving active treatment (treatment na(sqrroot) ve or previously treated) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

June 10, 2022, 4:30 p.m. usa

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) or patients with mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) or patients with mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

June 9, 2022, 4 p.m. usa

None

None

Jan. 5, 2022, 7 a.m. usa

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) or patients with mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) or patients with mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

Dec. 30, 2021, 4:30 a.m. usa

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: i. patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or ii. patients with fl and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) or iii. patients with mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents) c) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response d) age >= 18 years e) able to comprehend the investigational nature of the protocol and provide informed consent

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: i. patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination v. arm 5: must be receiving treatment with a bcl-2 inhibitor or ii. patients with fl and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) or iii. patients with mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents) c) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response d) age >= 18 years e) able to comprehend the investigational nature of the protocol and provide informed consent