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HIVPhase 2CARMENNCT01516593

Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma

A Phase 2 study testing Induction Phase, Consolidation Phase (on day +50) and Intensification phase in people with HIV and Burkitt's Lymphoma, run by Andres J. M. Ferreri at 8 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma. Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV, Burkitt's Lymphoma
What is being tested?
Induction Phase, Consolidation Phase (on day +50) and Intensification phase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
8 sitesItaly
Study dates
Nov 2011to Aug 2015
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
  • HIV sero-positivity
  • Age ≥18 and ≤60 years
  • ECOG-PS ≤3

Who cannot join

  • CNS parenchymal involvement
  • Absolute neutrophil count <1.000 cells/μL and platelets count <75 × 109/L (Burkitt unrelated)
  • Creatinine >1,5N (Burkitt unrelated)
  • SGOT and/or SGTP >2,5N (Burkitt unrelated)
  • Bilirubin >2N (Burkitt unrelated)
  • Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
  • Significant cardiac disease or acute myocardial infarction in the last 12 months
  • Severe active infection (except for HBV and/or HCV co-infection)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • Oncologia Medica A - Centro di Riferimento Oncologico

    Aviano (PN)

  • Ematologia - A.O. Spedali Civili

    Brescia

  • Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor

    Milan

  • S.C. Oncologia Medica - Ospedale San Paolo

    Milan

  • S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT)

    Milan

  • U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani

    Roma

  • S.C. Oncoematologia - A.O. Santa Maria

    Terni

  • U.O. Ematologia 2 - Ospedale San Giovanni Battista

    Torino

Other trials in Italy

About this study

Official title: Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma

This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma.

Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.

Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.

Read the detailed description

The activity of feasibility of the proposed program will be assessed in HIV+ patients with Burkitt lymphoma with the aim to improve tolerability, minimize source consuming and supporting treatment and redu ce late sequels. Available combinations in this setting are really source demanding and toxic combinations showing high rates of septic complication and a treatment-related mortality of near 20%.

Being tested
Induction Phase, Consolidation Phase (on day +50), Intensification phase, BEAM conditioning, Consolidation radiotherapy
Keywords
HIV, Burkitt's lymphoma, intensive, short term, immuno-chemotherapy, HIV-positive patients with Burkitt's lymphoma
Medical subject headings
Burkitt Lymphoma

What participants receive

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

  • Induction PhaseDrug

    Also called Short-term intensive sequential chemoimmunotherapy

    • dd -2 to 1: Methylprednisolone
    • dd 0-1, Cyclophosphamide, associated on day 0 with Vincristine
    • dd 2, Rituximab
    • dd 7, Methotrexate
    • dd 14, Rituximab
    • dd 15, Etoposide
    • dd 21, Methotrexate
    • dd 29, Rituximab and Doxorubicin
    • dd 36, Rituximab and VCR

    At the end of this induction phase, subsequent treatment will be performed according to the objective response:

    1. pts in CR: consolidation phase followed by bulky site irradiation
    2. pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
    3. pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation

  • Consolidation Phase (on day +50)Drug

    Also called high-dose cytarabine; consolidation phase

    • dd 1-2: cytarabine twice a day
    • dd 3 and 11: rituximab
    • dd 11-13: leukapheresis for PBPC collection.

  • Intensification phaseDrug

    Also called unresponsive patients, refractory disease

    1. One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking.
    2. CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13);
    3. AraC every 12 hours for four days (dd -5 to -2) supported by reinfusion of CD34+ cells (dd 0), rituximab infusion (dd -1 and +11) and second in-vivo purged PBPC collection (if needed).

  • BEAM conditioningDrug

    Also called Conditioning regimen, autologous transplantation

    BCNU on dd 1; VP-16 every 12 hours on dd 2-5 and araC every 12 hours on dd 2-5; melphalan on dd 6, followed by the reinfusion of CD34+ cells

  • Consolidation radiotherapyRadiation

    Also called bulky irradiation; residual lesion

    At the end of the whole program, patients will be evaluated for involved-field irradiation with 6-10 MeV photons and a dose of 36 Gy (2 Gy/d, five fractions a week). Three subgroups of patients will be considered for radiotherapy

Study groups in NCT01516593
Study groupRoleWhat they receive
intensive short term immuno-chemotherapyExperimentalExperimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
Receives: Drug: Induction Phase; Drug: Consolidation Phase (on day +50); Drug: Intensification phase; Drug: BEAM conditioning; Radiation: Consolidation radiotherapy

What is being measured

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

  1. evaluation of activity of the induction phase in terms of complete remission rate

    Objective lymphoma response achieved after the induction phase of the experimental treatment.

    Measured: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days

Secondary outcomes (4)

  1. Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events

    Assessment of incidence of grade 4 AE during experimental treatment (induction, consolidation and intensification phases as well as conditioning and autologous stem cell transplantation (if indicated)

    Measured: participants will be followed for the duration of the whole experimental program, an expected average of 100 days

  2. Feasibility and tolerability of the consolidation phase followed by BEAM conditioning and autologous stem cell transplantation in terms of prevalence of grade ≥4 adverse events

    Measured: participants will be followed for the duration of the whole experimental program, an expected average of 100 days

  3. Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events

    Participants who will not achieve a complete or partial response after induction and consolidation phases will be referred to intensification phase, which will be followed by BEAM + ASCT. These patients will be assess for tolerabbility and AE during these therapeutic phases.

    Measured: participants will be followed for the duration of the whole experimental program, an expected average of 100 days

  4. Activity of the whole investigational program in terms of complete remission rate

    Participants will be assessed by conventional exams to define complete remission rate after the whole experiemntal program; that is after consolidation phase for patients who achieved complete remission after induction phase, after BEAM + ASCt for patients who achieved partial response after induction phase, and after intensification phase for patients who did not achieve an objective response after induction phase.

    Measured: at the end of the whole program, an expected average of 100 days

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionApr 2013
  4. Study completionAug 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516593
Sponsor's protocol ID
CARMEN
Acronym
CARMEN
Status last verified
Aug 2022
First submitted
6 Jan 2012
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction Phase, Consolidation Phase (on day +50) and Intensification phase in people with HIV and Burkitt's Lymphoma, run by Andres J. M. Ferreri at 8 sites in Italy.

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 4 inclusion and 8 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. 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?

evaluation of activity of the induction phase in terms of complete remission rate (time frame: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days). 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 NCT01516593.

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 4 Aug 2022.

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