Primary Central Nervous System LymphomaPhase 2NCT02399189
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
A Phase 2 study testing R-MT followed by auto-HSCT in people with Primary Central Nervous System Lymphoma, run by Jun Zhu at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- R-MT followed by auto-HSCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Apr 2019
- 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
- primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy
- ECOG 0-2
- Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
- Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 50 ml/min/1.73m2
- Age 18-65 years
- Negative HIV test
- Signature of informed consent
Who cannot join
- prior chemotherapy for primary central nervous system lymphoma
- presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
- systemic lymphoma (outside the CNS)
- Isolated ocular lymphoma
- Immunosuppressed patients (HIV , use of immunosuppressors)
- Other uncontrolled or progressive disease compromising shot-term survival
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- Severe renal or hepatic disease
- Patients not legally covered by the French Social Security
- Inability to swallow the medication
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lijuan Deng
Beijing, Beijing Municipality, 100142
Lijuan Deng, MD, 1088196109, lijuan_deng@hotmail.com
Yuqin Song, MD, 1088196109, songyuqin622@sina.com
About this study
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.
Read the detailed description
It's a single center, single arm, prospective clinical trial. Patients younger than 65 years old with primary central nervous system lymphoma will received four cycles of chemotherapy with rituximab plus high-dose methotrexate and temozolomide as induction therapy, and then received consolidation therapy with autologous stem cell transplant for which the conditioning regimen is Carmustine plus thiotepa.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- R-MT followed by auto-HSCT
- Keywords
- Primary central nervous system lymphoma, rituximab, Methotrexate and Temozolomide, autologous stem cell transplantation, Carmustine and thiotepa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-MT followed by auto-HSCTDrug
Also called Methotrexate(M), Temozolomide(T), Rituximab(R)
Four cycles of Induction therapy: Rituximab 375mg/m2 d1; Methotrexate 3.5g/m2 d2;Temozolomide 100mg/m2 d2-6; for patients who reach a CR, PR, or SD, will proceed to autologous stem cell transplantation: Carmustine 400mg/m2 d1; Thiotepa 5mg/kg q12h, d2-3.
| Study group | Role | What they receive |
|---|---|---|
| R-MT followed by auto-HSCT | Experimental | R-MT followed by auto-HSCT Rituximab 375 mg/m2 d1 MTX 3.5g/m2 d2(0.5g/m2 15min,3g/m2 3h） TMZ 100 mg/m2 d2-6 Q21d*4cycles
Auto-HSCT conditioning regimen:
BCNU 400mg/m2 d1; Thiotepa 5mg/kg q12h，d2-3 Receives: Drug: R-MT followed by auto-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 2 years
Secondary outcomes (3)
overall response rate
Measured: 2 years
overall survival
Measured: 2 years
event-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399189
- Sponsor's protocol ID
- 20150301
- Status last verified
- Apr 2015
- First submitted
- 1 Mar 2015
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Correa DD, Maron L, Harder H, Klein M, Armstrong CL, Calabrese P, Bromberg JE, Abrey LE, Batchelor TT, Schiff D. Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol. 2007 Jul;18(7):1145-51. doi: 10.1093/annonc/mdl464. Epub 2007 Feb 6.
PubMed 17284616
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT02399189
- Acronym / sponsor ID
- 20150301
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- Primary central nervous system lymphoma, rituximab, Methotrexate and Temozolomide, autologous stem cell transplantation, Carmustine and thiotepa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Jun ZhuUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 26 Mar 2015 (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.
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.
Detailed description
It's a single center, single arm, prospective clinical trial. Patients younger than 65 years old with primary central nervous system lymphoma will received four cycles of chemotherapy with rituximab plus high-dose methotrexate and temozolomide as induction therapy, and then received consolidation therapy with autologous stem cell transplant for which the conditioning regimen is Carmustine plus thiotepa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-MT followed by auto-HSCT | Experimental | Drug: R-MT followed by auto-HSCTR-MT followed by auto-HSCT Rituximab 375 mg/m2 d1 MTX 3.5g/m2 d2(0.5g/m2 15min,3g/m2 3h） TMZ 100 mg/m2 d2-6 Q21d*4cycles Auto-HSCT conditioning regimen: BCNU 400mg/m2 d1; Thiotepa 5mg/kg q12h，d2-3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy
- ECOG 0-2
- Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
- Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 50 ml/min/1.73m2
- Age 18-65 years
Key exclusion criteria (9 listed)
- prior chemotherapy for primary central nervous system lymphoma
- presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
- systemic lymphoma (outside the CNS)
- Isolated ocular lymphoma
- Immunosuppressed patients (HIV , use of immunosuppressors)
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 |
|---|---|---|
| R-MT followed by auto-HSCTAlso: Methotrexate(M), Temozolomide(T), Rituximab(R)Four cycles of Induction therapy: Rituximab 375mg/m2 d1; Methotrexate 3.5g/m2 d2;Temozolomide 100mg/m2 d2-6; for patients who reach a CR, PR, or SD, will proceed to autologous stem cell transplantation: Carmustine 400mg/m2 d1; Thiotepa 5mg/kg q12h, d2-3. | Drug | R-MT followed by auto-HSCT |
Primary outcome
progression-free survival
Time frame: 2 years
3 secondary outcomes
overall response rate
Time frame: 2 years
overall survival
Time frame: 2 years
event-free survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Results publication: PubMed 17284616Correa DD, Maron L, Harder H, Klein M, Armstrong CL, Calabrese P, Bromberg JE, Abrey LE, Batchelor TT, Schiff D. Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol. 2007 Jul;18(7):1145-51. doi: 10.1093/annonc/mdl464. Epub 2007 Feb 6.
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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.
Jun Zhu, MD study chair
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-MT followed by auto-HSCT in people with Primary Central Nervous System Lymphoma, run by Jun Zhu at 1 site in China.
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 9 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact lijuan deng, MD (1099196109, lijuan_deng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2 years). 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 NCT02399189, 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 13 Apr 2015.