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

June 15, 2023 updated by: Hua Wang, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modifed BFM-95
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. 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.
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

Other Names:
  • Vincristine,Pirarubicin,Prednisone,Pegaspargase
Drug: 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
Other Names:
  • Cyclophosphamide,Cytarabine,Mercaptopurine
Drug: protocol M
Methotrexate: 5 g/m2 d 8, 22, 36, 50;Mercaptopurine:25 mg/m2 1-56
Other Names:
  • Methotrexate,Mercaptopurine
Drug: 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
Other Names:
  • 6-mercaptopurine,Methotrexate
Drug: 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

Other Names:
  • Vincristine,Pirarubicin,Prednisone,Pegaspargase
Drug: 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
Other Names:
  • Cyclophosphamide,Cytarabine,Mercaptopurine
Drug: 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
Other Names:
  • methotrexate ,cytarabine and dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: up to end of follow-up-phase (approximately 3 years)
up to end of follow-up-phase (approximately 3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to end of follow-up-phase (approximately 3 years)
up to end of follow-up-phase (approximately 3 years)
complete remission rate
Time Frame: every 4 weeks,up to completion of induction treatment(approximately 2months)
every 4 weeks,up to completion of induction treatment(approximately 2months)
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)
Time Frame: up to end of follow-up-phase (approximately 3 years)
up to end of follow-up-phase (approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hua Wang, MD., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimated)

March 24, 2015

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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