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Mantle Cell LymphomaPhase 3(R-HAD)NCT01449344

Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

A Phase 3 study testing Rituximab, High dose Ara-C and Dexamethasone in people with Mantle Cell Lymphoma, run by Prof. Dr. M. Dreyling (co-chairman) at 54 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Rituximab, High dose Ara-C and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
54 sitesin 2 countries
Study dates
9 May 2009to Dec 2018
Phase
Phase 3
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

  • Confirmed pathological diagnosis of MCL according to WHO classification.
  • Relapse or progression following 1 to 3 prior lines of anti-neoplastic standard therapy. Therapy in remission after initial induction like intensified chemotherapy for stem cell separation followed by myeloablative therapy or any kind of maintenance therapy is classified as one line of therapy with the induction therapy..
  • If Rituximab was part of prior treatment, documented time to progression must be at least 12 weeks after this particular regimen.
  • If high-dose Ara-C was part of prior treatment, documented time to progression must be at least 6 months after this particular regimen.
  • Patients relapsed after autologous stem cell transplantation or not appropriate for myeloablative treatment.
  • At least 1 measurable or assessable site of disease; in case of bone marrow infiltration only, bone marrow aspiration/ biopsy is mandatory for all staging evaluations.
Show all 18Show fewer
  • age > 18 years
  • ECOG/WHO Performance Score 0-2 unless lymphoma related.
  • The following laboratory values at screening, unless lymphoma related:
  • Absolute neutrophil count (ANC) > = 1500 cells/microlitre
  • Platelets > = 100,000 cells/microlitre
  • Transaminases (AST and ALT) <=3 x upper limit of normal (ULN)
  • Total bilirubin <=2 x ULN
  • Creatinine <=2 mg/dL or calculated creatinine clearance >=50 mL/min
  • Toxic effects of previous therapy or surgery resolved to NCI CTC grade 2 or better.
  • Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
  • Men must agree not to father a child for the duration of therapy and must agree to advice a female partner to use a highly effective method of birth control.
  • Written informed consent before performance of any study-related procedure.

Who cannot join

  • Previous treatment with Bortezomib
  • Treatment within another clinical trial within 30 days before trial entry or planned during this trial
  • Anti-neoplastic (including radiation and antibody treatment) or experimental therapy within 4 weeks before planed Day 1 of Cycle 1 (Nitrosoureas within 6 weeks ) or radioimmunoconjugates or toxin immunoconjugates such as Ibritumomab tiuxetan (Zevalin™) or Tositumomab (Bexxar®) within 12 weeks before planed Day 1 of Cycle 1
  • Known hypersensitivity to Rituximab, boron or mannitol.
  • Active malignancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy.
  • Active systemic infection requiring treatment.
Show all 11Show fewer
  • HIV, hepatitis B or C
  • Patient has >= grade 2 peripheral sensory neuropathy or neuropathic pain defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE).
  • Symptomatic degenerative or toxic encephalopathy
  • Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study
  • Female subject is pregnant or breast-feeding (pregnancy testing is mandatory for premenopausal women).

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

Germany33 sites

  • Kreisklinik Altötting-Burghausen, Sektion Hämatologie/Onkologie und Palliativmedizin

    Altötting, 84503

  • Klinikum St. Marien, Med. Klinik II

    Amberg, 92224

  • Vivantes Klinikum Neukölln, Medizinische Klinik I - Hämatologie und Onkologie

    Berlin, 12351

  • Knappschaftskrankenhaus, Onkologische Ambulanz

    Bottrop, 46242

  • Praxis für Hämatologie/Onkologie,

    Burgwedel, 30938

  • Klinikum der Universität zu Köln, Klinik I f. Innere Medizin

    Cologne, 50924

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

  • Universitätsklinik Essen, Klinik für Hämatologie

    Essen, 45147

  • Klinikum der J.W. Goethe-Universtität Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie

    Frankfurt am Main, 60590

  • Ernst-Moritz-Arndt-Universität, Hämatologie/Onkologie

    Greifswald, 17475

  • Kath. Krankenhaus Hagen gem. GmbH St.-Marien-Hospital

    Hagen, 58095

  • Asklepios Klinik St. Georg, Abteilung Hämatologie

    Hamburg, 20099

  • St.-Marien-Hopsital Gem. GmbH

    Hamm, 59071

  • Universitätsklinik des Saarlandes

    Homburg/Saar, 66421

  • Westpfalz-Klinikum GmbH, I. Medizinische Klinik

    Kaiserslautern, 67653

  • UKSH im Städt. Krankenhaus Kiel, II. Med. Klinik und Poliklinik im SSK

    Kiel, 24116

  • Praxis Dr. Vehling-Kaiser

    Landshut, 84028

  • Klinikum Magdeburg gemeinnützige GmbH, Klinik f. Hämatologie/Onkologie

    Magdeburg, 39130

  • Klinikum d. Phillips-Universität, Klinik für Innere Medizin Hämatol./Onkologie/Immunologie

    Marburg, 35033

  • Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

    Mönchengladbach, 41063

  • LMU München - Klinikum Großhadern Medizinische Klinik III

    München, 81377

  • Klinikum Schwäbisch Gmünd, Zentrum Innere Medizin

    Mutlangen, 73557

  • Klinikum Nord Nürnberg, 5. Med. Klinik, Onkologie/Hämatologie

    Nuremberg, 90419

  • Schlossberg Klinik, Oberstaufen Internistische Onkologie

    Oberstaufen, 87534

  • Diakonie Klinikum Jung Stilling Krankenhaus

    Siegen, 57074

  • Diakonieklinikum Stuttgart, Medizinische Klinik II

    Stuttgart, 70176

  • Robert-Bosch-Krankenhaus, Hämatologie/Onkologie

    Stuttgart, 70376

  • Mutterhaus der Borromäerinnen, Medizinische Abteilung

    Trier, 54219

  • Krankenhaus der Barmherzigen Brüder, 1. Medizinische Abteilung

    Trier, 54292

  • Universitätsklinikum Ulm, Innere Medizin III

    Ulm, 89081

  • Harz-Klinikum Wernigerode-Blankenburg GmbH, Innere Medizin, Hämato-Onkologie und Palliativmedizin

    Wernigerode, 38855

  • Ammerland-Klinik GmbH, Klinik für innere Medizin

    Westerstede, 26655

  • Heinrich-Braun-Krankenhaus, Klinik für Innere Medizin III

    Zwickau, 08060

Other trials in Germany

France21 sites

  • CH Victor Dupouy, Service hématologie

    Argenteuil, 95107

  • Centre Hospitalier de la côte Basque, Service hématologie

    Bayonne, 64109

  • CH de Blois, Service hématologie

    Blois, 41016

  • Institut Bergonie, Service Hématologie

    Bordeaux, 33076

  • CH Sud Francilien de Corbeil, Service hématologie

    Corbeil-Essonnes, 91106

  • Hôpital Henri Mondor, Service hématologie

    Créteil, 94010

  • Hôpital Albert Michallon, Service hématologie

    Grenoble, 38043

  • CH Mulhouse, Service hématologie

    Le Mans, 68070

  • Clinique Victor Hugo, Service hématologie

    Le Mans, 72015

  • CH du Mans, Service hématologie

    Le Mans, 72037

  • CHU de Nice, Service hématologie

    Nice, 06202

  • CHU Necker, Service d'hématologie - adulte

    Paris, 75015

  • Hôpital Haut Lévêque, Service hématologie

    Pessac, 33604

  • CHU Lyon Sud, Service hématologie

    Pierre-Bénite, 69495

  • Hôpital Jean Bernard, Service hématologie

    Poitiers, 86021

  • CH René Dubos, Service hématologie

    Pontoise, 95301

  • CHU Robert Debré, Service hématologie

    Reims, 51092

  • Hôpital Bretonneau, Service hématologie, Bâtiment H. Kaplan

    Tours, 37044

  • CHU Brabois, Service hématologie

    Vandœuvre-lès-Nancy, 54511

  • CH de Bretagne Atlantique, Service Hématologie

    Vannes, 56017

  • Institut Gustave ROUSSY

    Villejuif, 94805

Other trials in France

About this study

Official title: Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

Read the detailed description

This study is a prospective, randomized, multicenter, open-label phase III clinical trial to compare the efficacy and safety of Bortezomib in combination with Rituximab, high-dose Ara-C and dexamethasone (R-HAD) to R-HAD alone in patients with relapsed or refractory MCL after or not eligible for myeloablative treatment. The primary endpoint is time to treatment failure (TTF). Secondary endpoints are the complete response (CR) rate, the overall response (CR,PR) rate, the progression-free survival (PFS), the progression free survival of responders, the time to next lymphoma treatment, overall survival (OS), safety and tolerability of Rituximab, high-dose Ara-C and dexamethasone alone or in combination with Bortezomib. Study arms will be compared to each other to evaluate the impact of additional Bortezomib. Study arms will also be compared to historical controls.

Being tested
Rituximab, High dose Ara-C, Dexamethasone, Bortezomib
Keywords
relapsed, refractory
Medical subject headings
Lymphoma, Mantle-Cell, Recurrence

What participants receive

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

  • RituximabDrug

    Also called Rituximab:Rituxan

    Rituximab 375mg/m² IV , day 1

  • High dose Ara-CDrug

    Also called Ara-C: Cytarabine

    Ara-C 2000 mg/m² (patients >65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3

  • DexamethasoneDrug

    Also called Dexamethasone: none

    Dexamethasone 40 mg PO, day 1-4

  • BortezomibDrug

    Also called Bortezomib: Velcade

    Bortezomib 1.5 mg/m² IV, day 1 and 4

Study groups in NCT01449344
Study groupRoleWhat they receive
R-HAD + BortezomibExperimentalNot described
Receives: Drug: Rituximab; Drug: High dose Ara-C; Drug: Dexamethasone; Drug: Bortezomib
R-HADActive comparatorNot described
Receives: Drug: Rituximab; Drug: High dose Ara-C; Drug: Dexamethasone

What is being measured

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

  1. Change from Baseline of diseased nodes and nodal masses.

    Average time frame is three weeks after the first two cycles of trial therapy and 4 to 6 weeks after the end of trial therapy.

    Response is always evaluated in comparison to the status before start of trial therapy. The assessment will be done with CT of all known lymphoma manifestations. In case of isolated bone marrow involvement a bone marrow aspiration/ biopsy is mandatory. A minimum of 50 % decrease in SPD (sum of the products of the greatest diameters) of the six largest nodes or nodal masses are necessary, in order to be able to evaluate it as partly remission.

    Measured: approx. 66 and 126 days after start of therapy

Timeline

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

  1. First posted10 Oct 2011 (estimated)
  2. Study start9 May 2009
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01449344
Sponsor's protocol ID
MCL2005-01
Acronym
(R-HAD)
Status last verified
Mar 2017
First submitted
28 Sep 2011
Last updated
7 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Fischer L, Jiang L, Durig J, Schmidt C, Stilgenbauer S, Bouabdallah K, Solal-Celigny P, Scholz CW, Feugier P, de Wit M, Trappe RU, Hallek M, Graeven U, Hanel M, Hoffmann M, Delwail V, Macro M, Greiner J, Giagounidis AAN, Dargel B, Durot E, Foussard C, Silkenstedt E, Weigert O, Pott C, Klapper W, Hiddemann W, Unterhalt M, Hoster E, Ribrag V, Dreyling M. The addition of bortezomib to rituximab, high-dose cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma-a randomized, open-label phase III trial of the European mantle cell lymphoma network. Leukemia. 2024 Jun;38(6):1307-1314. doi: 10.1038/s41375-024-02254-2. Epub 2024 Apr 27.

    PubMed 38678093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, High dose Ara-C and Dexamethasone in people with Mantle Cell Lymphoma, run by Prof. Dr. M. Dreyling (co-chairman) at 54 sites in 2 countries.

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 18 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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Germany, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Change from Baseline of diseased nodes and nodal masses. (time frame: approx. 66 and 126 days after start of therapy). 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 NCT01449344, which also lists 1 linked publication.

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 7 Mar 2017.

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