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MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma

Sponsor
Jun Zhu (Other)
Overall Status
Unknown status
CT.gov ID
NCT02399189
Collaborator
(none)
39
Enrollment
1
Location
1
Arm
59
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: R-MT followed by auto-HSCT
 Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
Study Start Date :
May 1, 2014
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: R-MT followed by auto-HSCT

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

Drug: R-MT followed by auto-HSCT
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.
Other Names:
  • Methotrexate(M)
  • Temozolomide(T)
  • Rituximab(R)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [2 years]

    Secondary Outcome Measures

    1. overall response rate [2 years]

    2. overall survival [2 years]

    3. event-free survival [2 years]

    Other Outcome Measures

    1. neurotoxicity [2 years]

      using a battery of cognitive and quality-of-life (QoL) measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    • Severe renal or hepatic disease

    • Patients not legally covered by the French Social Security

    • Inability to swallow the medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lijuan Deng Beijing Beijing China 100142

    Sponsors and Collaborators

    • Jun Zhu

    Investigators

    • Study Chair: Jun Zhu, MD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Zhu, Chief of the department of lymphoma, Peking University
    ClinicalTrials.gov Identifier:
    NCT02399189
    Other Study ID Numbers:
    • 20150301
    First Posted:
    Mar 26, 2015
    Last Update Posted:
    Apr 13, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Jun Zhu, Chief of the department of lymphoma, Peking University
    Primary central nervous system lymphoma
    rituximab
    Methotrexate and Temozolomide
    autologous stem cell transplantation
    Carmustine and thiotepa
    Additional relevant MeSH terms:
    Lymphoma
    Methotrexate
    Temozolomide

    Study Results

    No Results Posted as of Apr 13, 2015