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Trial record 5 of 47 for:    "Central Nervous System Lymphoma" | "Vitamin B Complex"

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

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ClinicalTrials.gov Identifier: NCT02399189
Recruitment Status : Unknown
Verified April 2015 by Jun Zhu, Peking University.
Recruitment status was:  Recruiting
First Posted : March 26, 2015
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

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
Primary Central Nervous System Lymphoma 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
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 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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)




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. overall response rate [ Time Frame: 2 years ]
  2. overall survival [ Time Frame: 2 years ]
  3. event-free survival [ Time Frame: 2 years ]

Other Outcome Measures:
  1. neurotoxicity [ Time Frame: 2 years ]
    using a battery of cognitive and quality-of-life (QoL) measures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399189


Contacts
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Contact: lijuan deng, MD 1099196109 lijuan_deng@hotmail.com
Contact: Yuqin Song, MD 1088196109 songyuqin622@sina.com

Locations
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China, Beijing
Lijuan Deng Recruiting
Beijing, Beijing, China, 100142
Contact: Lijuan Deng, MD    1088196109    lijuan_deng@hotmail.com   
Contact: Yuqin Song, MD    1088196109    songyuqin622@sina.com   
Sponsors and Collaborators
Jun Zhu
Investigators
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Study Chair: Jun Zhu, MD Beijing Cancer Hospital

Publications of Results:
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Responsible Party: Jun Zhu, Chief of the department of lymphoma, Peking University
ClinicalTrials.gov Identifier: NCT02399189     History of Changes
Other Study ID Numbers: 20150301
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Jun Zhu, Peking University:
Primary central nervous system lymphoma
rituximab
Methotrexate and Temozolomide
autologous stem cell transplantation
Carmustine and thiotepa

Additional relevant MeSH terms:
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Folic Acid Antagonists
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Methotrexate
Thiotepa
Temozolomide
Carmustine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents