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AzTrials

HIV InfectionsPhase 1/2NCT00432419

Therapeutic Intensification of HIV-associated Non-Hodgkin's Lymphoma by Peripheral Blood Cell Transplantation Following Chemotherapy.

A Phase 1/2 study testing autologous peripheral blood cell transplantation in people with HIV Infections and Lymphoma, Non-Hodgkin, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high incidence in HAART era, more intensive therapy is required in patients with initially severe stage of NHL or relapsing after first-line chemotherapy. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
HIV Infections, Lymphoma, Non-Hodgkin
What is being tested?
autologous peripheral blood cell transplantation
Type of treatment
Surgery or procedure
How many people
1 participants
Where
1 siteFrance
Study dates
Feb 2007to Oct 2008
Phase
Phase 1/2
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients between 18 and 55 years old at screening
  • Documented HIV-1 infection
  • Currently HAART-treated
  • Plasma HIV-RNA below 50 copies/ml at screening
  • Lymphocyte T CD4+ count above or equal to 100/mm3 at the NHL diagnosis
  • Histologically proven large cell NHL in first remission with classical poor prognostic factors (IPI above or equal to 2) or in second remission whatever IPI.
Show all 9Show fewer
  • Biological criteria of eligibility for intensive therapeutic
  • Signed written informed consent
  • Patient protected by the social security of one of the European community countries.

Who cannot join

  • Burkitt NHL
  • Central nervous system NHL
  • Patients already treated by ASCT
  • Ongoing infectious disease
  • Psychiatric disease
  • Left ventricular ejection fraction < 25%
Show all 11Show fewer
  • Creatinine clearance < 50 ml/min
  • Hepatic failure
  • Uncontrolled high blood pressure
  • Chronic hepatitis C or B
  • Participating in other trials.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Servide d'Immunologie Clinique

    Créteil, 94010

Other trials in France

About this study

Official title: Therapeutic Intensification for HIV-associated Non-Hodgkin's Lymphoma by Autologous Transplantation of Either Unselected or CD34+-Selected Peripheral Blood Stem Cells, in Patients in First or Second Complete Remission. ANRS 131

Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high incidence in HAART era, more intensive therapy is required in patients with initially severe stage of NHL or relapsing after first-line chemotherapy.

The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by peripheral blood cell transplantation in these patients.

Read the detailed description

Highly active antiretroviral therapy (HAART) has dramatically reduced mortality and morbidity of HIV-infected patients by decreasing the incidence of opportunistic infections and HIV-related malignancies such as Kaposi sarcoma. However, the frequency of NHL remains increased in these patients. Moreover, their prognostic remains poor comparing to HIV negative patients. This is mainly due to the type of NHL (aggressive B, and frequent stage IV) but also host factors such as immunodeficiency, co-infections (EBV, HHV8), and chemotherapy-HAART interactions. In the lack of new and significantly more efficient treatments, therapeutic intensification such as high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation (ASCT), already tested in relapsed or partially responding HIV negative patients, could be an option in HAART controlled HIV+ patients with NHL, rather in first complete remission (CR) but with initially high International Prognosis Index (IPI above or equal to 2), or in second CR, whatever initial IPI. Positive selection CD34+ cells is an approach for depleting grafts of tumour cells and HIV DNA. However the delayed lymphocyte recovery following this process, may lead to increased incidence of opportunistic infections (OI) in HIV-infected patients. OI prophylaxis will be systematically associated.

Eligible patients will have peripheral blood stem cell (PBSC) mobilization and divided in two subgroups. Group A with 3-6 x 106 PBSC will not undergo CD34+ selection process and group B with more than 6 x 106 will undergo this process. The myeloablative conditioning process is the same in the two groups with total body irradiation before reinfusion of grafts.

Patients will be followed from week2 (W2) up to W60 with clinical and biological evaluations.

Being tested
autologous peripheral blood cell transplantation
Keywords
HIV, Non-Hodgkin's lymphoma, Peripheral blood stem cells transplantation
Medical subject headings
HIV Infections, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous peripheral blood cell transplantationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety criteria defined as the occurrence of grades 3 or 4 adverse events in the 6 months following transplantation.

Secondary outcomes (8)

  1. Evaluation of:

  2. HIV RNA

  3. HIV DNA

  4. Percentage and absolute count of CD3, CD4+ and CD8+ lymphocytes

  5. Lymphocyte phenotypes and functions

  6. TREC analysis

  7. Immune reconstitution in vivo

  8. Duration of aplasia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJul 2008
  4. Study completionOct 2008

Why it stopped: only one patient enrolled

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00432419
Sponsor's protocol ID
ANRS131
Status last verified
Dec 2011
First submitted
5 Feb 2007
Last updated
22 Dec 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing autologous peripheral blood cell transplantation in people with HIV Infections and Lymphoma, Non-Hodgkin, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

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 9 inclusion and 11 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 22 Dec 2011. 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 France. 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 combined 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.

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 was stopped early (reason given: only one patient enrolled). 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?

Safety criteria defined as the occurrence of grades 3 or 4 adverse events in the 6 months following transplantation.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00432419.

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 22 Dec 2011.

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