NCT01208896

Brief Summary

This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell transplantation including Rituximab in the conditioning regimen for the treatment of relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control of the disease and a better prophylaxis of the graft versus host disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

February 3, 2011

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

6.7 years

First QC Date

September 23, 2010

Last Update Submit

August 8, 2018

Conditions

Lymphoma, FollicularStem Cell Transplantation

Keywords

Allogeneic hematopoietic stem cell transplantationReduced-intensity conditioningChemosensitive relapsed follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    2 year

Secondary Outcomes (7)

  • Toxic mortality

    2 year

  • Progression free survival

    2 year

  • Incidence of relapse

    2 year

  • Grade II-IV acute GVHD incidence

    2 year

  • Chronic GVHD incidence

    2 year

  • +2 more secondary outcomes

Study Arms (1)

Rituximab

EXPERIMENTAL
Drug: Reduced_intensity conditioning

Interventions

Reduced_intensity conditioningDRUG

The conditioning regimen is composed of Fludarabine (30 mg/m2) and Cyclophosphamide (750 mg/m2), both administered intravenously at Days -5, -4, -3 with Day 0 being the day of transplantation. Rituximab will be administered intravenously at 375 mg/m2 at Day -13 and 1000 mg/m2 at Days -6, +1, +8. Tacrolimus and low-doses of methotrexate will be used for prophylaxis of GVHD.

Rituximab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and ≤ 65 years
  • Follicular lymphoma confirmed by a biopsy at the last relapse.
  • nd, 3rd or 4th complete or partial response according to Cheson's criteria 1 (Annexe 1)
  • Relapse after autologous-SCT except if the absence of autologous SCT is due to a failure of collecting peripheral stem cells or investigator decision to not proceed to the autologous graft because of serious criteria
  • Relapse after at least one line of treatment with rituximab
  • Karnofsky index \> 70%
  • HLA Matched related or unrelated donor (10/10 matching; HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1)
  • Signed informed consent

You may not qualify if:

  • Stable or progressive disease according to Cheson's criteria1 (Annexe 1)
  • Absence of treatment with rituximab before the last relapse
  • Cardiac insufficiency (ejection fraction \< 50% by echocardiography)
  • Pulmonary disease characterized by DLCO \< 60%
  • Renal insufficiency (clearance of creatinin \< 60 ml/min)
  • Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin \> 2 times the upper normal value except in case of Gilbert's disease or hepatic lymphoma
  • HIV positive test
  • Bacterial, Viral or Fungal uncontrolled infections
  • Pregnant or breast feeding woman
  • Cancer in the last 5 years except in case of cutaneous baso-cellular cancer or epithelioma "in situ" of the uterine cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

University Hospital Angers

Angers, Angers, 49033, France

Location

Service Hématologie, Hôpital Minjoz

Besançon, 25030, France

Location

Service Hématologie, Hôpital Augustin Morvan

Brest, 29609, France

Location

University Hospital, Caen

Caen, France

Location

Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHRU Lille

Lille, 59037, France

Location

CHU Limoges

Limoges, 87042, France

Location

Hôpital Edouard Herriot

Lyon, 69374, France

Location

Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

Montpellier, 34295, France

Location

CHU Nancy

Nancy, 54511, France

Location

Service Hématologie Clinique, CHU -Hôtel Dieu

Nantes, 44093, France

Location

Service Hématologie Clinique, Hôpital Archet 1

Nice, 06202, France

Location

APHP Hôpital Necker-Enfants malades

Paris, 75015, France

Location

APHP Hôpital Saint Louis

Paris, 75475, France

Location

APHP Hôpital Pitié-Salpêtrière

Paris, 75651, France

Location

APHP Hôpital Henri-Mondor

Paris, 94010, France

Location

Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

Pessac, 33600, France

Location

CHU Poitiers - La Milétrie

Poitiers, 86000, France

Location

Service Hématologie Clinique, Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, France

Location

Institut de Cancérologie de la Loire

Saint-Etienne, 60008, France

Location

Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

Strasbourg, 67098, France

Location

Service Hématologie, Hôpital Purpan

Toulouse, 31059, France

Location

CHRU Tours

Tours, 37000, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (5)

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PMID: 17242396BACKGROUND

  • Khouri IF, Saliba RM, Giralt SA, Lee MS, Okoroji GJ, Hagemeister FB, Korbling M, Younes A, Ippoliti C, Gajewski JL, McLaughlin P, Anderlini P, Donato ML, Cabanillas FF, Champlin RE. Nonablative allogeneic hematopoietic transplantation as adoptive immunotherapy for indolent lymphoma: low incidence of toxicity, acute graft-versus-host disease, and treatment-related mortality. Blood. 2001 Dec 15;98(13):3595-9. doi: 10.1182/blood.v98.13.3595.

    PMID: 11739162BACKGROUND

  • Khouri IF, McLaughlin P, Saliba RM, Hosing C, Korbling M, Lee MS, Medeiros LJ, Fayad L, Samaniego F, Alousi A, Anderlini P, Couriel D, de Lima M, Giralt S, Neelapu SS, Ueno NT, Samuels BI, Hagemeister F, Kwak LW, Champlin RE. Eight-year experience with allogeneic stem cell transplantation for relapsed follicular lymphoma after nonmyeloablative conditioning with fludarabine, cyclophosphamide, and rituximab. Blood. 2008 Jun 15;111(12):5530-6. doi: 10.1182/blood-2008-01-136242. Epub 2008 Apr 14.

    PMID: 18411419BACKGROUND

  • Vigouroux S, Michallet M, Porcher R, Attal M, Ades L, Bernard M, Blaise D, Tabrizi R, Garban F, Cassuto JP, Chevalier P, Facon T, Ifrah N, Renaud M, Tilly H, Vernant JP, Kuentz M, Bourhis JH, Bordigoni P, Deconinck E, Lioure B, Socie G, Milpied N; French Society of Bone Marrow Graft Transplantation and Cellular Therapy (SFGM-TC). Long-term outcomes after reduced-intensity conditioning allogeneic stem cell transplantation for low-grade lymphoma: a survey by the French Society of Bone Marrow Graft Transplantation and Cellular Therapy (SFGM-TC). Haematologica. 2007 May;92(5):627-34. doi: 10.3324/haematol.10924.

    PMID: 17488686BACKGROUND

  • Christopeit M, Schutte V, Theurich S, Weber T, Grothe W, Behre G. Rituximab reduces the incidence of acute graft-versus-host disease. Blood. 2009 Mar 26;113(13):3130-1. doi: 10.1182/blood-2009-01-200527. No abstract available.

    PMID: 19324911BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Stéphane VIGOUROUX, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 24, 2010

Study Start

February 3, 2011

Primary Completion

September 28, 2017

Study Completion

September 28, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(26)