Primary Central Nervous System LymphomaPhase 2PRECISNCT00863460
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
A Phase 2 study testing cranial radiotherapy, intensive chemotherapy and hematopoietic stem cell rescue and MTX based chemotherapy in people with Primary Central Nervous System Lymphoma, run by Institut Curie at 23 sites in France.
Trial summary
Purpose of the study : To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- cranial radiotherapy, intensive chemotherapy and hematopoietic stem cell rescue and MTX based chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 23 sitesFrance
- Study dates
- 3 Oct 2008to May 2026
- 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
- Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
- All histological types of non-Hodgkin's lymphoma, except MALT
- Age > 18 and < 60 ans.
- Negative for HIV, HCV and HBV
- Written informed consent -
Who cannot join
- Age < 18 or > 60 ans
- Isolated intra-ocular lymphoma
- Previous history of indolent lymphoma
- Previous chemotherapy or radiotherapy for PCNSL
- Isolated CNS relapse of systemic NHL
- Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
Show all 12Show fewer
- Renal insufficiency or creatinin clearance < 60 ml/min
- Liver enzymes > 3N.
- Platelets < 100 000/mm3 or neutrophils < 1500/mm3)
- Previous history of organ transplantation or other cause of severe immunodeficiency
- Pregnancy or active sexual women with no contraception
- Unable to follow the protocol for any reason
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Cancérologie Hôpital Sud
Amiens, 80054
Chu D'Angers
Angers
CHR Argenteuil
Argenteuil, 95100
CHU de Besancon
Besançon
Institut Bergonié
Bordeaux, 33076
CHU Hôtel Dieu
Clermont-Ferrand
CHU Michalon
Grenoble, 38043
Centre Hospitalier Lens
Lens
CHU de Limoges
Limoges, 87042
CHU de la Timone
Marseille, 13009
Hôtel Dieu Nantes
Nantes
Centre Antoine Lacassagne
Nice
CHU de Nimes
Nîmes
GH Pitié-Salpétrière
Paris, 75013
CHG Saint Jean
Perpignan, 66046
CHU Hôpital Bernard
Poitiers, 86021
Chu Reims
Reims
Hôpital Pontchaillou
Rennes, 35033
Centre René Huguenin
Saint-Cloud, 92210
Institut de Cancérologie
Saint-Priest-en-Jarez
CH de Saint-Quentin
Saint-Quentin
Hôpital Bretonneau
Tours
CHU Nancy - Hôpital Neurologique
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)
Purpose of the study :
To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- cranial radiotherapy, intensive chemotherapy and hematopoietic stem cell rescue, MTX based chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranial radiotherapyRadiation
40 Gy
intensive chemotherapy and hematopoietic stem cell rescueDrug
Also called Thiotepa IV (250 mg/m²/day) day-9 day-8 day-7, Busulfan IV (0.8 mg/kg X 10) day-6 to day-4, Cyclophosphamide IV (60 mg/kg/day) day-3 & day-2, Reinjection of hematopoietic stem cells day0
intensive chemotherapy and hematopoietic stem cell rescue
MTX based chemotherapyDrug
Also called R-RMVP :, Rituximab IV if LNH type B (375 mg/m²) day1, Methotrexate IV (3g/m² during 30 minutes) day1 and day15, Etoposide IV (100 mg/m²) day2
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\&59 and days79\&80
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | MTX-based chemotherapy followed by WBRT Receives: Radiation: cranial radiotherapy; Drug: MTX based chemotherapy |
| B | Experimental | MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue Receives: Drug: intensive chemotherapy and hematopoietic stem cell rescue; Drug: MTX based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-years progression-free survival in each arm
Measured: 2 years after inclusion
Secondary outcomes (4)
Overall response rate at the end of the procedure
Measured: at the end of procedure at 1 and 2 years
Overall survival
Measured: 2 years after inclusion
Event-free survival
Measured: 2 years after inclusion
Neurotoxicity
Measured: each years during ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study start3 Oct 2008
- Primary completion17 May 2016
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Hoffmann-La Roche, Amgen, Pierre Fabre Laboratories
- Responsible party
- Sponsor
- Investigators
- Carole Soussain, MD, Principal investigator, Institut Curie - Hôpital René Huguenin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863460
- Sponsor's protocol ID
- CRH 07/422/H
- Other IDs
- EudraCT N° 2007-005378-30
- Acronym
- PRECIS
- Status last verified
- Feb 2019
- First submitted
- 16 Mar 2009
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.
PubMed 35834762Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20.
PubMed 30785830
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)
- ClinicalTrials.gov ID
- NCT00863460
- Acronym / sponsor ID
- PRECIS / CRH 07/422/H
- Conditions
- Primary Central Nervous System Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Hoffmann-La Roche, Amgen, Pierre Fabre Laboratories
- Study start
- 3 Oct 2008 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study :
To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Radiation: cranial radiotherapy, Drug: MTX based chemotherapyMTX-based chemotherapy followed by WBRT |
| B | Experimental | Drug: intensive chemotherapy and hematopoietic stem cell rescue, Drug: MTX based chemotherapyMTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
- All histological types of non-Hodgkin's lymphoma, except MALT
- Age > 18 and < 60 ans.
- Negative for HIV, HCV and HBV
- Written informed consent -
Key exclusion criteria (12 listed)
- Age < 18 or > 60 ans
- Isolated intra-ocular lymphoma
- Previous history of indolent lymphoma
- Previous chemotherapy or radiotherapy for PCNSL
- Isolated CNS relapse of systemic NHL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cranial radiotherapy40 Gy | Radiation | A |
| intensive chemotherapy and hematopoietic stem cell rescueAlso: Thiotepa IV (250 mg/m²/day) day-9 day-8 day-7, Busulfan IV (0.8 mg/kg X 10) day-6 to day-4, Cyclophosphamide IV (60 mg/kg/day) day-3 & day-2, Reinjection of hematopoietic stem cells day0intensive chemotherapy and hematopoietic stem cell rescue | Drug | B |
| MTX based chemotherapyAlso: R-RMVP :, Rituximab IV if LNH type B (375 mg/m²) day1, Methotrexate IV (3g/m² during 30 minutes) day1 and day15, Etoposide IV (100 mg/m²) day2R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\&59 and days79\&80 | Drug | A, B |
Primary outcome
2-years progression-free survival in each arm
Time frame: 2 years after inclusion
4 secondary outcomes
Overall response rate at the end of the procedure
Time frame: at the end of procedure at 1 and 2 years
Overall survival
Time frame: 2 years after inclusion
Event-free survival
Time frame: 2 years after inclusion
Neurotoxicity
Time frame: each years during ten years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 35834762Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.
- Derived from this study: PubMed 30785830Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Soussain, MD principal investigator
Institut Curie - Hôpital René Huguenin
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cranial radiotherapy, intensive chemotherapy and hematopoietic stem cell rescue and MTX based chemotherapy in people with Primary Central Nervous System Lymphoma, run by Institut Curie at 23 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 5 inclusion and 12 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
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?
2-years progression-free survival in each arm (time frame: 2 years after inclusion). 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 NCT00863460, which also lists 2 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 5 Feb 2019.