PreleukemiaPhase 1NCT00943293
Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
A Phase 1 study testing Fludarabine, Melphalan and Campath in people with Preleukemia and Myeloproliferative Disorders, run by University of Chicago at 1 site in United States.
Trial summary
This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preleukemia, Myeloproliferative Disorders, Lymphoma
- What is being tested?
- Fludarabine, Melphalan and Campath
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory acute myelogenous or lymphoid leukemia.
- Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
- Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma at high risk for disease recurrence.
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
Who cannot join
- Clinical progression.
- Contra-indications for vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).
- Being tested
- Fludarabine, Melphalan, Campath
- Keywords
- GVHD
- Medical subject headings
- Preleukemia, Myeloproliferative Disorders, Lymphoma, Neoplasms, Plasma Cell, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.
MelphalanDrug
Melphalan 140 mg/m2 IV on day -2.
CampathDrug
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Not described Receives: Drug: Fludarabine; Drug: Melphalan; Drug: Campath |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity.
Measured: 5 years
Secondary outcomes (1)
To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startMay 2003
- Primary completionSep 2011
- Study completionJan 2012
Why it stopped: Poor accrual; did not enter phase 2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreleukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Artz, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943293
- Sponsor's protocol ID
- 12175A
- Status last verified
- Mar 2014
- First submitted
- 20 Jul 2009
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00943293
- Acronym / sponsor ID
- 12175A
- Keywords
- GVHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual; did not enter phase 2
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 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.
This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Drug: Fludarabine, Drug: Melphalan, Drug: Campath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Relapsed or refractory acute myelogenous or lymphoid leukemia.
- Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
- Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
Key exclusion criteria (2 listed)
- Clinical progression.
- Contra-indications for vaccination.
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 |
|---|---|---|
| FludarabineFludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3. | Drug | Vaccine |
| MelphalanMelphalan 140 mg/m2 IV on day -2. | Drug | Vaccine |
| CampathCampath, 20 mg IV on day -7, 6, -5, -4, and -3. | Drug | Vaccine |
Primary outcome
To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity.
Time frame: 5 years
1 secondary outcome
To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Poor accrual; did not enter phase 2). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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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.
Andrew Artz, M.D. principal investigator
University of Chicago
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 Fludarabine, Melphalan and Campath in people with Preleukemia and Myeloproliferative Disorders, run by University of Chicago 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 8 inclusion and 2 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: stopped early, as of the sponsor's last update on 17 Mar 2014. 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?
The study was stopped early (reason given: Poor accrual; did not enter phase 2). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity. (time frame: 5 years). 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 17 Mar 2014; AzTrials last refreshed its copy on 6 Nov 2026.