Possibia

2396043

Last Update Posted: 2023-06-18

Recruiting

All Genders

accepted

18 Years-65 Years

50 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

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

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.

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.

Eligibility

Relevant conditions:

Lymphoma, Lymphoblastic

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

Hua Wang, MD.

wanghua@sysucc.org.cn

0086-02087342438

Data sourced from ClinicalTrials.gov