Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT00968630
Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
A Phase 2 study testing Laboratory Biomarker Analysis and Leukapheresis in people with Hematopoietic and Lymphoid Cell Neoplasm and HIV Infection, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection
- What is being tested?
- Laboratory Biomarker Analysis and Leukapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2009to 17 Mar 2017
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV positive
- Treatment with highly active antiretroviral therapy (HAART) for at least 1 month
- Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy
- Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated
- Approval for allogenic regimen given at Patient Care Conference
- DONOR: Autologous or allogeneic gene modified cells allowed
Who cannot join
- A medical history of noncompliance with HAART or medical therapy
- Inability to provide informed consent
- DONOR: Allogeneic donors must not have HIV infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV
This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients.
II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.
OUTLINE:
Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.
- Being tested
- Laboratory Biomarker Analysis, Leukapheresis
- Medical subject headings
- Hematologic Neoplasms, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
LeukapheresisProcedure or surgery
Also called Leukocytopheresis, Therapeutic Leukopheresis
Undergo leukapheresis
| Study group | Role | What they receive |
|---|---|---|
| Treatment (HIV-specific immune reconstitution after HCT) | Experimental | Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible. Receives: Other: Laboratory Biomarker Analysis; Procedure: Leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of donor-derived HIV-1-specific immune responses following HCT
HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
Measured: Up to 1 year
Quantification of latently infected CD4+ cells in HIV+ patients
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study start17 Dec 2009
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Ann Woolfrey, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968630
- Sponsor's protocol ID
- 2212.00
- Other IDs
- NCI-2009-01244, 2212, 2212.00, P01CA018029, P30CA015704, U19AI096111
- Status last verified
- May 2017
- First submitted
- 28 Aug 2009
- Last updated
- 24 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV
- ClinicalTrials.gov ID
- NCT00968630
- Acronym / sponsor ID
- 2212.00
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Dec 2009 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 31 Aug 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 phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.
Detailed description
PRIMARY OBJECTIVES:
- Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients.
II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.
OUTLINE:
Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (HIV-specific immune reconstitution after HCT) | Experimental | Other: Laboratory Biomarker Analysis, Procedure: LeukapheresisPatients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- HIV positive
- Treatment with highly active antiretroviral therapy (HAART) for at least 1 month
- Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy
- Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated
- Approval for allogenic regimen given at Patient Care Conference
Key exclusion criteria (3 listed)
- A medical history of noncompliance with HAART or medical therapy
- Inability to provide informed consent
- DONOR: Allogeneic donors must not have HIV infection
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (HIV-specific immune reconstitution after HCT) |
| LeukapheresisAlso: Leukocytopheresis, Therapeutic LeukopheresisUndergo leukapheresis | Procedure or surgery | Treatment (HIV-specific immune reconstitution after HCT) |
Primary outcome
Quantification of donor-derived HIV-1-specific immune responses following HCT
Time frame: Up to 1 year
HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
Quantification of latently infected CD4+ cells in HIV+ patients
Time frame: Up to 7 years
The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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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.
Ann Woolfrey principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis and Leukapheresis in people with Hematopoietic and Lymphoid Cell Neoplasm and HIV Infection, run by Fred Hutchinson Cancer Center 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 24 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of donor-derived HIV-1-specific immune responses following HCT (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 24 May 2017.