First-line chemotherapy for adults with T-lymphoblastic lymphoma
Modified BFM-95 Regimen for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults:a Prospective Phase II Study
PHASE2 · Sun Yat-sen University · NCT02396043
This study is testing a new chemotherapy plan to see if it helps adults with T-lymphoblastic lymphoma feel better and stay in remission over two years.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (GuangZhou, Guangdong) |
| Trial ID | NCT02396043 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and tolerability of a modified BFM-95 regimen for treating adults with T-lymphoblastic lymphoma (T-LBL). Patients will undergo a series of treatment phases including induction, reinduction, and maintenance therapy over a total duration of 24 months. The regimen includes high-dose methotrexate with specific modifications, such as the use of citrovorum folinate for rescue and alternative drugs like pirarubicin and pegaspargase. Treatment response will be assessed through tumor regression and complete remission evaluations using PET/CT scans.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with newly diagnosed T-LBL at Ann Arbor stages IE to IVE and at least one measurable lesion.
Not a fit: Patients with systemic central nervous system involvement or those with previous malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for adults diagnosed with T-lymphoblastic lymphoma.
How similar studies have performed: Other studies using modified chemotherapy regimens for lymphoblastic lymphoma have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * newly diagnosedT-LBL * age:18-65years * Ann Arbor stage IEto stage IVE * at lease one measurable lesion * receive no chemotherapy or radiotherapy before * Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal) Exclusion Criteria: * mismatch the inclusion criteria * systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
Where this trial is running
GuangZhou, Guangdong
- Sun Yat-sen University Cancer Center — GuangZhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Hua Wang, MD. — Sun Yat-sen University
- Study coordinator: Hua Wang, MD.
- Email: wanghua@sysucc.org.cn
- Phone: 0086-02087342438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoma, Lymphoblastic