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Lymphoma, FollicularPhase 2RITALLONCT01208896

Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma

A Phase 2 study testing Reduced_intensity conditioning in people with Lymphoma, Follicular and Stem Cell Transplantation, run by University Hospital, Bordeaux at 26 sites in France.

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 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Reduced_intensity conditioning
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
26 sitesFrance
Study dates
3 Feb 2011to 28 Sep 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 65 years
  • Follicular lymphoma confirmed by a biopsy at the last relapse.
  • 2nd, 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • University Hospital Angers

    Angers, Angers, 49033

  • Service Hématologie, Hôpital Minjoz

    Besançon, 25030

  • Service Hématologie, Hôpital Augustin Morvan

    Brest, 29609

  • University Hospital, Caen

    Caen

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

    Clermont-Ferrand, 63000

  • CHU Grenoble

    Grenoble, 38043

  • CHRU Lille

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • Hôpital Edouard Herriot

    Lyon, 69374

  • Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

    Montpellier, 34295

  • CHU Nancy

    Nancy, 54511

  • Service Hématologie Clinique, CHU -Hôtel Dieu

    Nantes, 44093

  • Service Hématologie Clinique, Hôpital Archet 1

    Nice, 06202

  • APHP Hôpital Necker-Enfants malades

    Paris, 75015

  • APHP Hôpital Saint Louis

    Paris, 75475

  • APHP Hôpital Pitié-Salpêtrière

    Paris, 75651

  • APHP Hôpital Henri-Mondor

    Paris, 94010

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

    Pessac, 33600

  • CHU Poitiers - La Milétrie

    Poitiers, 86000

  • Service Hématologie Clinique, Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen

  • Institut de Cancérologie de la Loire

    Saint-Etienne, 60008

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

    Strasbourg, 67098

  • Service Hématologie, Hôpital Purpan

    Toulouse, 31059

  • CHRU Tours

    Tours, 37000

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Safety and Efficacy of a Strategy of Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Chemosensitive Relapsed Follicular Lymphoma

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.

Read the detailed description

Follicular lymphomas are chemosensitive neoplasms characterized by a relentless succession of remissions and relapses when treated with conventional chemotherapy. The successive periods of remission are of shorter duration and patients invariably die of their disease. At first line, patients are treated with conventional chemotherapy. At first relapse, intensive chemotherapy with autologous stem cell transplantation (SCT) is often proposed.

Allogeneic hematopoietic stem cell transplantation after reduced-intensity conditioning (RIC-allo) is an option for patients relapsing after autologous SCT, allowing long-term progression free survival of 50 to 60%. The toxic mortality related to severe acute graft versus host disease (GVHD) remains a critical issue. The goal of our study is to test in a multicentric approach a strategy of RIC-allo including rituximab in order to reduce the incidence of acute GVHD.

Around half of patients with relapsed or refractory follicular lymphomas treated with allogeneic SCT achieve long-term progression free survival whatever the conditioning regimen. Because the median age of patients with follicular lymphoma is 55 years, a reduced intensity conditioning is the most appropriate option in this setting. The outcome of patients with a chemoresistant disease is usually poor because of a high toxic mortality. As a consequence, only patients with a chemosensitive disease will be included in this study. To further reduce the toxic mortality, it is critical to reduce the incidence of severe acute GVHD. A low incidence of acute GVHD could be obtained by the use of Rituximab before and after the transplantation as reported by the MD Anderson's experience in several hematological malignancies including follicular lymphoma. Their results are impressive in patients with follicular lymphoma with long-term survival of 85%. The favored hypothesis is a depletion of patient and donor B cells reducing the presentation of minor histocompatibility alloantigens. The benefit of Rituximab could also be explained by its anti-lymphoma effects that could compensate the putative reduction of a graft versus lymphoma effect due to a better control of GVHD.

The primary objective is to estimate 2-year overall survival in this setting.

Being tested
Reduced_intensity conditioning
Keywords
Allogeneic hematopoietic stem cell transplantation, Reduced-intensity conditioning, Chemosensitive relapsed follicular lymphoma
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • 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.

Study groups in NCT01208896
Study groupRoleWhat they receive
RituximabExperimentalNot described
Receives: Drug: Reduced_intensity conditioning

What is being measured

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

  1. Overall survival

    Measured: 2 year

Secondary outcomes (7)

  1. Toxic mortality

    Measured: 2 year

  2. Progression free survival

    Measured: 2 year

  3. Incidence of relapse

    Measured: 2 year

  4. Grade II-IV acute GVHD incidence

    Measured: 2 year

  5. Chronic GVHD incidence

    Measured: 2 year

  6. Morbidity and adverse event

    Measured: 2 year

  7. Hematologic reconstitution, Immunologic reconstitution, Chimerism

    Measured: 2 years

Timeline

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

  1. First posted24 Sep 2010 (estimated)
  2. Study start3 Feb 2011
  3. Primary completion28 Sep 2017
  4. Study completion28 Sep 2017

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01208896
Sponsor's protocol ID
CHUBX 2009/09
Other IDs
2009-013422-17, 2009
Acronym
RITALLO
Status last verified
Aug 2018
First submitted
23 Sep 2010
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 17242396

  • 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.

    PubMed 11739162

  • 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.

    PubMed 18411419

  • 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.

    PubMed 17488686

  • 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.

    PubMed 19324911

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Reduced_intensity conditioning in people with Lymphoma, Follicular and Stem Cell Transplantation, run by University Hospital, Bordeaux at 26 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 8 inclusion and 10 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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.

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?

Overall survival (time frame: 2 year). 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 NCT01208896, which also lists 5 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 12 May 2026.

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