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Non Hodgkin LymphomaPALM2NCT01541072

Lymphocyte Reconstitution After Administration of Pegfilgrastim Versus Filgrastim After Peripheral Stem Cell Transplantation

A study testing Pegfilgrastim and Filgrastim in people with Non Hodgkin Lymphoma, run by Centre Leon Berard at 2 sites 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

The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
Pegfilgrastim and Filgrastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesFrance
Study dates
Feb 2012to Sep 2014
Phase
Interventional
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

  • Age ≥ 18 years.
  • Patients with B-cell NHL, except Burkitt Lymphoma and primary brain lymphoma, as first-line or second-line therapy, with planed BICNU, etoposide, aracytine and melphalan (BEAM) chemotherapy after pre-inclusion.
  • Minimum one mobilization with G-CSF, G-CSF and endoxan or mozobil
  • Minimum one cytapheresis with CD34>2 millions CD34/kg for stem cell transplantation
  • Patients hospitalized in the investigational center throughout the procedure and until recovery from aplasia (neutrophils> 0.5 G/L)
  • Mandatory affiliation with a health insurance system
  • Subjects must provide written informed consent prior to performance of study-specific assessments

Who cannot join

  • Patients already treated with intensive chemotherapy and autologous stem cell transplantation
  • Total irradiation exposure (patients with partial irradiation exposure can be included in the study)
  • Intolerance to one of the two studied growth factors, or hypersensitivity to one of their components
  • Patients with neutropenia (neutrophils <1.2 G/L) or thrombopenia (platelets < 100 G/L) before intensive chemotherapy
  • Acquired immune deficiency syndrome, seropositivity
  • Pregnant or lactating women (pregnancy test, for women of childbearing potential, should be negative, in blood or urine, at inclusion time)
  • Impossibility to comply with protocol constraints because of geographical, psychiatric, social or family reasons
  • Deprived of liberty (court judgement or administrative decision)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU Clermont-Ferrand, Hôpital d'Estaing

    Clermont-Ferrand, 63000

  • Centre Leon Berard

    Lyon

Other trials in France

About this study

Official title: Lymphocyte Reconstitution in a Randomized Study After Administration of Pegfilgrastim Versus Filgrastim in Patients With B-cell Non-Hodgkin Lymphoma Treated With High-dose Chemotherapy and Autologous Peripheral Stem Cell Transplantation

The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation.

Read the detailed description

High dose chemotherapy with autologous peripheral stem cell transplantation is a standard consolidation treatment used in patients with non-Hodgkin lymphoma, in first or second line of treatment. This procedure is associated with prolonged neutropenia and considerable morbidity. Different guidelines have recommended the use of growth factor after peripheral stem cell transplantation.Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) resulting from the modification of Filgrastim by chemical addition of a polyethylene glycol(PEG) moiety which increases its half-life by decreasing its renal clearance. Then, a single injection substitutes several Filgrastim injections. The trial "PALM" realized by our team has shown, between these 2 molecules, an equivalent efficacy on the duration of chemotherapy-induced febrile neutropenia in patients treated for lymphoma or myeloma. This trial has also shown that Pegfilgrastim is a cost-effectiveness dominant strategy.

Some studies have shown that a rapid lymphocyte reconstitution after stem cell transplantation is associated with better overall survival and progression-free survival.

In the present PALM2 study, the investigators want to describe the kinetics of different lymphocyte subsets reconstitution within 3 and 6 months after transplantation, in patients with B-cell malignant non-Hodgkin lymphoma, in first or second-line chemotherapy and first autologous transplantation. The investigators will assess the kinetics of reconstitution for T-lymphocytes (Naïve T-lymphocytes, regulatory T-cells and memory T-cells), B-lymphocytes (transitional B cells), cytotoxic T-cells and natural killer T-cells, dendritic cells. A preliminary phase to this assessment will consist in estimate intra-center variability of lymphocyte phenotyping.

Keywords
Lymphoma, B-cell, Lymphocyte reconstitution, Lymphocyte subsets, Peripheral stem cell transplantation, Induction chemotherapy, growth factor, Granulocyte Colony-stimulating factor, Pegfilgrastim, Filgrastim
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

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

  • PegfilgrastimDrug

    Also called Neulasta, AMGEN Laboratories

    Pegfilgrastim (Neulasta®, AMGEN Laboratories): single subcutaneous administration of Pegfilgrastim, 6 mg at day 5 (D5) after autologous stem cell transplantation

  • FilgrastimDrug

    Also called Neupogen, AMGEN Laboratories

    Filgrastim (Neupogen®, AMGEN Laboratories): daily subcutaneous administration, 5µg/kg/day from day 5 (D5) after autologous stem cell transplantation until recovery from aplasia (Neutrophils >= 0.5 G/L)

Study groups in NCT01541072
Study groupRoleWhat they receive
PegfilgrastimExperimentalNot described
Receives: Drug: Pegfilgrastim
FilgrastimActive comparatorNot described
Receives: Drug: Filgrastim

What is being measured

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

  1. 3 months kinetics of lymphocyte reconstitution, in the two arms

    Measured: Lymphocyte count within the 3 months post transplantation

Secondary outcomes (10)

  1. 6 months kinetics of lymphocyte reconstitution, in the two arms

    Measured: Lymphocyte count within the 6 months post transplantation

  2. 6 months kinetics of lymphocyte subsets reconstitution by phenotyping, in the 2 arms

    Measured: In the transplant and within the 6 months after transplantation (at Day 15, D30, D90, D180 after transplantation)

  3. Average duration of neutropenia and thrombopenia, in the 2 arms

    1. neutrophils<0.5 G/L
    2. neutrophils<1 G/L
    3. platelets<20 G/L
    4. platelets<50 G/L

    Measured: Within the 3 months post transplantation

  4. Number of days with temperature ≥38°, in the 2 arms

    Measured: For duration of post transplantation hospital stay, an expected average of 2 weeks

  5. Number of bacterial and/or viral and/or fungal infection longer than 7 days, average duration of anti-viral, anti-fungal and antibiotic treatments, in the 2 arms

    Measured: Within 3 months post transplantation

  6. Number of red blood cell units and platelets concentrates transfused to patient, in the 2 arms

    Measured: Within 3 months post transplantation

  7. Evaluation of duration of Filgrastim treatment, in arm "Filgrastim"

    Measured: For duration of post transplantation hospital stay, an expected average of 2 weeks

  8. Overall survival

    Measured: Within 18 months after the first inclusion, from the date of randomization until the date of death from any cause

  9. Progression free survival

    The progression is measured as per 2007 Cheson international response criteria. Cheson BD et al. Revised response criteria for malignant lymphoma. J of Clin Oncol 2007;25(5):579-586

    Measured: Within 18 months after yhe first inclusion, from the date of randomization until the date of the first documented progression or death from any cause, whichever came first

  10. Average duration of febrile neutropenia (with neutrophils<0.5 G/L and temperature ≥38°), in the 2 arms

    Measured: For duration of post transplantation hospital stay, an expected duration of 2 weeks

Timeline

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

  1. First posted29 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2014
  4. Study completionSep 2014

Why it stopped: Number of enrolled patients was insufficient during planned inclusion time.

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541072
Sponsor's protocol ID
ET2011-010
Other IDs
2011-A00662-39
Acronym
PALM2
Status last verified
Oct 2016
First submitted
17 Feb 2012
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Dieckmann D, Plottner H, Berchtold S, Berger T, Schuler G. Ex vivo isolation and characterization of CD4(+)CD25(+) T cells with regulatory properties from human blood. J Exp Med. 2001 Jun 4;193(11):1303-10. doi: 10.1084/jem.193.11.1303.

    PubMed 11390437

  • Goguel AF, Crainic K, Ducailar A, Ouin M. Interlaboratory quality assessment of lymphocyte phenotyping. Etalonorme 1990-1992 surveys. Biol Cell. 1993;78(1-2):79-84. doi: 10.1016/0248-4900(93)90118-x.

    PubMed 8220229

  • Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130.

    PubMed 12123336

  • Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.

    PubMed 11821454

  • Joao C, Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Markovic SN. Early lymphocyte recovery after autologous stem cell transplantation predicts superior survival in mantle-cell lymphoma. Bone Marrow Transplant. 2006 May;37(9):865-71. doi: 10.1038/sj.bmt.1705342.

    PubMed 16532015

  • Jonuleit H, Schmitt E, Stassen M, Tuettenberg A, Knop J, Enk AH. Identification and functional characterization of human CD4(+)CD25(+) T cells with regulatory properties isolated from peripheral blood. J Exp Med. 2001 Jun 4;193(11):1285-94. doi: 10.1084/jem.193.11.1285.

    PubMed 11390435

  • Noether, G. E. Sample size determination for some common nonparametric statistics. Journal of the American Statistical Association 82 : 645-47, 1987.

  • Peggs KS. Immune reconstitution following stem cell transplantation. Leuk Lymphoma. 2004 Jun;45(6):1093-101. doi: 10.1080/10428190310001641260.

    PubMed 15359987

  • Porrata LF, Gertz MA, Inwards DJ, Litzow MR, Lacy MQ, Tefferi A, Gastineau DA, Dispenzieri A, Ansell SM, Micallef IN, Geyer SM, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous hematopoietic stem cell transplantation in multiple myeloma or non-Hodgkin lymphoma. Blood. 2001 Aug 1;98(3):579-85. doi: 10.1182/blood.v98.3.579.

    PubMed 11468153

  • Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Litzow MR, Winters JL, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous stem cell transplantation in non-Hodgkin lymphoma: a prospective study. Biol Blood Marrow Transplant. 2008 Jul;14(7):807-16. doi: 10.1016/j.bbmt.2008.04.013.

    PubMed 18541201

  • Porrata LF, Inwards DJ, Micallef IN, Ansell SM, Geyer SM, Markovic SN. Early lymphocyte recovery post-autologous haematopoietic stem cell transplantation is associated with better survival in Hodgkin's disease. Br J Haematol. 2002 Jun;117(3):629-33. doi: 10.1046/j.1365-2141.2002.03478.x.

    PubMed 12028034

  • Reimer P, Kunzmann V, Wilhelm M, Weissbrich B, Kraemer D, Berghammer H, Weissinger F. Cellular and humoral immune reconstitution after autologous peripheral blood stem cell transplantation (PBSCT). Ann Hematol. 2003 May;82(5):263-70. doi: 10.1007/s00277-003-0630-4. Epub 2003 Mar 22.

    PubMed 12739062

  • Roberts MM, To LB, Gillis D, Mundy J, Rawling C, Ng K, Juttner CA. Immune reconstitution following peripheral blood stem cell transplantation, autologous bone marrow transplantation and allogeneic bone marrow transplantation. Bone Marrow Transplant. 1993 Nov;12(5):469-75.

    PubMed 7905331

  • Sebban, C., Lefranc, A, Perrier, L., Morreau, P., Espinouse, D., Moles-Moreau, M-P, Kammoun, L, Ghesquieres, H, Segura-Ferlay, C., Bay, J-O, Lissandre, S, PEROL, D, Michallet, M, and Quittet, P. A Randomized Phase II Study Evaluating the Efficacy, Safety and Cost-Effectiveness of Pegfilgrastim and Filgrastim After High Dose Chemotherapy and Autologous Stem Cell Transplantation In Patients with Lymphoma and Myeloma (PALM Study). ASH . 4-12-2010. Ref Type: Abstract

  • Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.

    PubMed 10553041

Questions about this trial

What is this clinical trial studying?

A study testing Pegfilgrastim and Filgrastim in people with Non Hodgkin Lymphoma, run by Centre Leon Berard at 2 sites 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 7 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: stopped early, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

The study was stopped early (reason given: Number of enrolled patients was insufficient during planned inclusion time.). 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?

3 months kinetics of lymphocyte reconstitution, in the two arms (time frame: Lymphocyte count within the 3 months post 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 NCT01541072, which also lists 20 linked publications.

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 1 Nov 2016.

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