Trial Outcomes & Findings for Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma (NCT NCT00006478)

Results Overview

evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression

Results posted on

2023-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccine Therapy vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
Overall Study STARTED	19
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaccine Therapy vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
Overall Study Vaccine could not be produced	1
Overall Study Physician Decision	6

Baseline Characteristics

Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine Therapy n=19 Participants vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 10.68 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression

Population: NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.

evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At each immunization and at study completion

Population: The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.

To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At each immunization and at study completion

Population: The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.

To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year post transplant evaluation and then annually until disease progression

Population: The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.

To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.

Outcome measures

Outcome data not reported

Adverse Events

Vaccine Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bryan Ludwig, Regulatory Coordinator

University of Nebraska Medical Center Division of Oncology/Hematology

Phone: 402-559-8071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place