Relapsed Non-Hodgkin's LymphomaPhase 1NCT00935597
Host Dendritic Cells in Allograft Patients
A Phase 1 study testing MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) in people with Relapsed Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- What is being tested?
- MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Ability to sign informed consent
- ECOG performance status ≤3
- Life expectancy > 6 months
- Adequate cardiac function: MUGA or Echocardiogram demonstrating >50% Ejection Fraction
- Adequate pulmonary function with DLCO > 50%
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- Adequate hepatic function
- Bilirubin ≤ 1.5mg/dl
- Alkaline phosphatase ≤5 times the upper limit of normal
- Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transferase (SGOT) ≤ 3 times the upper limit of normal
- Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≤ 3 times the upper limit of normal
- Adequate renal function Estimated creatinine clearance > 40ml/min
- Diagnosis of one of the following
- Non-Hodgkin's lymphoma excluding Follicular lymphoma and Marginal Zone Lymphoma
- Hodgkin's lymphoma
- Multiple myeloma
- Chronic lymphocytic leukemia
- Eligible for allogeneic stem cell transplant with identified HLA-identical sibling (6/6 HLA match) or volunteer unrelated donor (8/8 allele HLA-matched (A, B, Cw, DRB1)
- Women of childbearing potential must have a negative serum pregnancy test prior to enrollment
- Women of childbearing potential must use effective means of birth control throughout the study.
- Men should not father a child while enrolled in the study. Effective means of birth control include condom, vasectomy or abstinence.
Who cannot join
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
- Prior allogeneic stem cell transplant
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- History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- Active infections including fungal infections and viral hepatitis
- GVHD greater than grade I GVHD of the skin
- Patient Exclusion Criteria for Part B (post Stem Cell Transplant)
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study.
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
- Prior allogeneic stem cell transplant
- More than 4 prior relapses
- History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- Active infections including fungal infections and viral hepatitis
- GVHD greater than grade I GVHD of the skin
- No cytotoxics will be given within 4 weeks of administration of the investigational cell therapy
- Patients cannot receive any investigational agents within 30 days prior to administration of the investigational cell therapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
Keren Osman, MD, 212-241-6021
Keren Osman, MD
About this study
Official title: A Phase I Trial of Host Dendritic Cell Infusion After Allogeneic Stem Cell Transplant for Prevention or for Treatment of Relapsed Disease in Patients With Advanced Hematologic Malignancies
The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.
- Conditions
- Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma
- Being tested
- MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
- Keywords
- Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma, Relapsed Non-Hodgkin's lymphoma (excluding follicular lymphoma and marginal zone lymphoma)
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)Biological
Patients who have minimal residual disease or minimal volume relapse, and are at least four weeks post immunosuppression following allogeneic stem cell transplantation will receive a series of four HDC infusions (100,000 HDC/kg per infusion, one every four weeks(group 1). Those patients who have greater than minimal residual disease will receive HDC infusions, one every four weeks in conjunction with donor lymphocyte infusion (DLI) (group 2).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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 Receives: Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) |
| Group 2 | Experimental | 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) Receives: Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
Measured: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
Secondary outcomes (1)
The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism
Measured: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Keren Osman, M.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935597
- Sponsor's protocol ID
- 08-0906
- Status last verified
- Oct 2010
- First submitted
- 7 Jul 2009
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Host Dendritic Cell Infusion After Allogeneic Stem Cell Transplant for Prevention or for Treatment of Relapsed Disease in Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00935597
- Acronym / sponsor ID
- 08-0906
- Conditions
- Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma
- Keywords
- Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma, Relapsed Non-Hodgkin's lymphoma (excluding follicular lymphoma and marginal zone lymphoma)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2013 (estimated)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)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 |
| Group 2 | Experimental | Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18-70
- Ability to sign informed consent
- ECOG performance status ≤3
- Life expectancy > 6 months
- Adequate cardiac function: MUGA or Echocardiogram demonstrating >50% Ejection Fraction
Key exclusion criteria (22 listed)
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)Patients who have minimal residual disease or minimal volume relapse, and are at least four weeks post immunosuppression following allogeneic stem cell transplantation will receive a series of four HDC infusions (100,000 HDC/kg per infusion, one every four weeks(group 1). Those patients who have greater than minimal residual disease will receive HDC infusions, one every four weeks in conjunction with donor lymphocyte infusion (DLI) (group 2). | Biological | Group 1, Group 2 |
Primary outcome
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
Time frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
1 secondary outcome
The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism
Time frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keren Osman, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) in people with Relapsed Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keren Osman, MD ((212)241-6021, keren.osman@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading. (time frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010; AzTrials last refreshed its copy on 26 Oct 2026.