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Cancer Vaccine
Host Dendritic Cell Therapy for Lymphoma
Phase 1
Waitlist Available
Led By Keren Osman, M.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤3
Adequate pulmonary function with DLCO > 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks following each hdc infusion and 4, 6 and 8 weeks after the last hdc infusion
Awards & highlights
Study Summary
This trial is testing whether a specific type of cell therapy can help people with cancer after a stem cell transplant, and whether it is safe and feasible.
Who is the study for?
This trial is for adults aged 18-70 with certain blood cancers like Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia who are eligible for a stem cell transplant. Participants must have good heart, lung, liver and kidney function and not be pregnant or nursing. They should agree to use birth control and cannot have had prior treatments that might interfere with the study.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a vaccine made from dendritic cells (HDC Vax-001) in patients after they've received an allogeneic stem cell transplant. Some participants will also receive donor lymphocyte infusions. The process involves shipping collected immune cells to create the vaccine which is then returned for patient treatment.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions related to immune system stimulation such as fever, fatigue or pain at injection site; organ inflammation due to immune response; or complications from donor lymphocyte infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am capable of limited self-care.
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My lung function is more than half of what is considered normal.
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My liver is functioning within the required limits.
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My kidneys are working well.
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I am between 18 and 70 years old.
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I have a specific type of blood cancer and am eligible for a stem cell transplant.
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My heart pumps well, with an ejection fraction over 50%.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks following each hdc infusion and 4, 6 and 8 weeks after the last hdc infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks following each hdc infusion and 4, 6 and 8 weeks after the last hdc infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
Secondary outcome measures
The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Patients with greater than Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion in conjunction with donor lymphocyte infusion (DLI)
Group II: Group 1Experimental Treatment1 Intervention
Patients with Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,261 Total Patients Enrolled
Keren Osman, M.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am capable of limited self-care.Women who could become pregnant must have a negative pregnancy test before joining the study.I have had a stem cell transplant from a donor.I haven't had any cancer except skin cancer or cervical pre-cancer in the last 5 years.I do not have any illnesses that would shorten my life to less than 6 months, aside from my current condition.I have a history of autoimmune diseases like lupus, rheumatoid arthritis, or thyroiditis.I do not have any active infections, including fungal or hepatitis.My skin condition after a transplant is worse than mild.My kidneys are working well.I haven't received chemotherapy in the last 4 weeks.My lung function is more than half of what is considered normal.My liver is functioning within the required limits.I am using effective birth control methods or abstaining.I have received a donor lymphocyte infusion before.You are expected to live for more than 6 months.I am between 18 and 70 years old.I have a specific type of blood cancer and am eligible for a stem cell transplant.I am HIV positive.I am using effective birth control methods during the study.My heart pumps well, with an ejection fraction over 50%.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 60 or older eligible to join this experiment?
"To be accepted into this medical study, patients must fall within the 18 to 70 years old age range. 339 trials are available for those aged under 18 while 2402 studies have been designed with seniors in mind."
Answered by AI
Is this experiment accepting participants at present?
"Clinicaltrials.gov states that this medical trial is not currently open for recruitment, despite having been originally posted on August 1st 2009 and last updated on October 28th 2010. However, there are still 2570 other trials actively searching for participants."
Answered by AI
Has the FDA sanctioned MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) for therapeutic use?
"The safety of the MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) is appraised to be a 1, as it is currently in Phase 1 trials where efficacy and safety data are both scarce."
Answered by AI
Under what conditions is one eligible to participate in this trial?
"To be eligible to participate in this trial, participants must have a diagnosis of multiple myeloma and should lie within the age range of 18-70. Approximately 25 subjects are required for successful completion of the study."
Answered by AI
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