Modified BFM-95 Regimen as First-Line Chemotherapy in Adults With T- Lymphoblastic Lymphoma

Lymphoma, Lymphoblastic Clinical Trial

Official title:

Modified BFM-95 Regimen for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults:a Prospective Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02396043
• Other study ID #: LBL-308
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: Hua Wang, MD.
• Phone: 0086-02087342438
• Email: wanghua[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to modified BFM-95 regimen for acute lymphoblastic leukemia.

Description:

All patients received a modified BFM regimen which was derived from the NHL-BFM-95. The differences were as follows: (1) during the course of high-dose methotrexate therapy (HD-MTX), citrovorum folinate (CF) was used for rescue at 36 h after the administration of HD-MTX;(2) Pirarubicin was used instead of daunorubicin (3) Pegaspargase was used instead of L-asparaginase for patients.All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate [MTX] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. CNS-positive patients received two additional doses of intrathecal MTX at days 18 and 27 of induction and received CRT after reinduction therapy. The dose was 18 Gy.Patients with identifiable blasts in CSF-cytospin preparation but less than 5cells/uL in CSF were not considered CNS positive but received two additional doses of intrathecal MTX at days 18 and 27. For men with testicular involvement,orchiectomy was not performed, and irradiation (20 Gy) of testes was to be confined to biopsy-proven persistent infiltration of testis after protocol M.Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Lymphoblastic
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• induction phase1
Vincristine: 1.5 mg/m2 (max 2 mg) iv on days1, 8, 15, 22,Pirarubicin: 30 mg/m2 iv on days1, 8, 15, 22,Prednisone: 60 mg/m2 po on days 1-28. Pegaspargase :3750U/m2 im on days 8,22
• induction phase2
Cyclophosphamide: 1000 mg/m2 iv on days 35, 59,Cytarabine: 75 mg/m2 iv on days 35-38, 42-45, 49-52, 56-59,Mercaptopurine: 60 mg/m2 po on days 35-59
• protocol M
Methotrexate: 5 g/m2 d 8, 22, 36, 50;Mercaptopurine:25 mg/m2 1-56
• maintenance therapy
6-mercaptopurine , 50 mg/m 2 daily, and Methotrexate, 20 mg/m 2 once a week.The treatment lasted 2.0 years.Note that there were four additional doses of HD-MTX(5 g/m2 ) every 3 months during the maintenance phase
• reinduction phase1
Vincristine: 1.5 mg/m2 (max 2 mg) iv on days1, 8, 15, 22,Pirarubicin: 30 mg/m2 iv on days1, 8, 15, 22,Prednisone: 60 mg/m2 po on days 1-28. Pegaspargase :3750U/m2 im on days 8
• reinduction phase2
Cyclophosphamide: 1000 mg/m2 iv on days 29,Cytarabine: 75 mg/m2 iv on days 31-34, 38-41,Mercaptopurine: 60 mg/m2 po on days 29-42
• Intrathecal (IT)
methotrexate (15 mg/m 2 ), cytarabine (40 mg/m 2 ) and dexamethasone (4 mg).induction :d1, 15, 29, 45 ;Protocol M:d1, 15, 29, 43;Reinduction:d31,38

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang K, Chen X, Wuxiao Z, Wang Z, Sun X, Zeng Z, Li S, Xia ZJ. Long-term outcomes of modified Berlin-Frankfurt-Munster-90 regimen in adults with T-lymphoblastic lymphoma: a single-center experience. Leuk Lymphoma. 2014 Aug;55(8):1800-5. doi: 10.3109/10428 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		up to end of follow-up-phase (approximately 3 years)
Secondary	complete remission rate		every 4 weeks,up to completion of induction treatment(approximately 2months)
Secondary	overall survival		up to end of follow-up-phase (approximately 3 years)
Secondary	safety, including hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)		up to end of follow-up-phase (approximately 3 years)