High-dose gemcitabine, busulfan, and thiotepa with autologous stem cell transplant for primary central nervous system lymphoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, prospective phase 2 trial gives high-dose gemcitabine, busulfan, and thiotepa as a conditioning regimen prior to autologous stem cell transplantation in patients with primary or relapsed CNS lymphoma. Gemcitabine is administered IV on Days -9 and -3, busulfan IV on Days -9 to -7, thiotepa IV on Days -5 to -3, and peripheral stem cells are infused on Day 0. Patients are followed with clinic visits and imaging according to International Primary CNS Lymphoma Group recommendations to monitor safety and disease response. The study's main outcomes are the regimen's safety profile and measures of disease control after transplant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. age between 18 and 70 years;
2. CNS status of complete remission (CR) or partial response (PR) as assessed by magnetic resonance imaging (MRI), positron emission tomography-computed tomography (PET/CT), or CSF analysis (if applicable);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2;
4. absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by CT and bone marrow biopsy;
5. negative HIV and hepatitis virus infections (particularly hepatitis B or C, with HBV DNA ≥ 10,000 copies/mL);
6. left ventricular ejection fraction (LVEF) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease;
7. forced expiratory volume in one second (FEV1) ≥70%;
8. serum creatinine clearance ≥ 50 ml/min and/or serum creatinine ≤ 1.8 mg/dL;
9. serum bilirubin ≤ 2 times the upper limit of normal, serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) ≤ 3 times the upper limit of normal.

Exclusion Criteria:

1. relapse after stem cell transplantation;
2. other uncontrolled malignancies;
3. immunodeficiency;
4. active infection requiring parenteral antibiotics;
5. pregnant or lactation;
6. severe psychiatric or psychological conditions.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Jie Ji, MD
• Email: jieji@scu.edu.cn
• Phone: 86-28-85422373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.