NCT02934204

Brief Summary

Consolidation treatment for Primary Central Nervous System Diffuse Large B cell Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 14, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

October 13, 2016

Last Update Submit

October 13, 2016

Conditions

Primary CNS Lymphoma

Keywords

PCNSLDLBCLmethotrexatetemozolomide

Outcome Measures

Primary Outcomes (1)

  • event free survival

    3 year

Secondary Outcomes (3)

  • Chronic neurotoxicity

    3 year

  • Overall survival

    3 year

  • Completed response

    3 year

Study Arms (1)

MTX and Temozolomide

EXPERIMENTAL

Induction therapy: Methotrexate 3.5g/m2 ivgtt d1 2weeks/cycle，total 8 cycles Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 4 cycles Consolidation therapy: PCNSL patients achieve CR,Temozolomide 150mg/m2 po d1-5 4weeks/cycle, total 12 cycles

Drug: methotrexateDrug: temozolomide

Interventions

methotrexateDRUG
MTX and Temozolomide
temozolomideDRUG
MTX and Temozolomide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- (1) histology confirmed to be PCNSL. (2) lymphoma invasion in brain, meninges, cerebrospinal fluid, eye organ. (3) ECOG score less than 3 points (4) at least 1 of the lesions can be evaluated with a double diameter. (5) the life expectancy of more than 6 months. (6) less or equal to 75 years,or more or equal to 18 years. (7) to be able to comply with the requirements of the study and follow-up procedures.
  • (8) to sign the consent form to participate in the study. (9) having adequate organ function, defined as follows: Liver function, serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) equal to or less than 2 times the upper limit of normal (ULN).
  • Bone marrow function: absolute neutrophil count more or equal to 1500/L, platelet count more than 100000/L,hemoglobin was greater than 9 g/dL.
  • Renal function, serum creatinine or creatinine clearance rate (less than 1.5ULN Cockcroft-Gault formula based on the improvement of more than 50ml/min).
  • (10) women with childbearing potential must start to get the test results of serum / urine pregnancy test negative within 48 hours prior to study. Postmenopausal women who have at least 12 months of menopause can be treated as non fertile.

You may not qualify if:

  • (1) patients with a history of other malignancies within five years (except for the full treatment of cervical carcinoma in situ or basal cell carcinoma or squamous cell skin cancer).
  • (2) had previously been treated with total cranial irradiation. (3) the upper digestive tract is lack of physical integrity, or suffering from malabsorption syndrome, or oral drug, or active gastric ulcer.
  • (4) suffering from any unstable systemic diseases (including active infection, significant cardiovascular disease, any significant liver and kidney or metabolic disorders), metabolic disorders, physical examination results or laboratory examination results of contraindication to the use of drugs, or may affect the treatment results of interpretation or increase the risk of complications in treatment of risk (5) patients with human immunodeficiency virus (HIV) transmitted in the form of blood or other body fluids.
  • (6) women in pregnancy and lactation. (7) women of childbearing age who do not want to use contraceptive measures during the study period and have sexual capacity of men.
  • (8) patients who do not want to sign informed consent. (9) patients who were not willing to follow up. (10) for any drugs or excipients of allergy. Exit the case: no matter what reason patients withdrew from the study of cases in time will be postponed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong general hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

MethotrexateTemozolomide

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Wenyu Li, MD PhD

CONTACT

+86 20 81884713LiWY1206@163.com

Sichu Liu, MD PhD

CONTACT

+86 20 81884713sisi.lau@foxmail.com

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

October 13, 2016

First Posted

October 14, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

October 14, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)