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

NCT02396043 | Unknown Phase 2 DMC

• 1 other identifier: LBL-308
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, Lymphoblastic

Outcome Measures

Primary Outcomes (1)

• progression free survival

  up to end of follow-up-phase (approximately 3 years)

Secondary Outcomes (3)

• complete remission rate

  every 4 weeks,up to completion of induction treatment(approximately 2months)

• overall survival

  up to end of follow-up-phase (approximately 3 years)

• 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)

Study Arms (1)

Modifed BFM-95

EXPERIMENTAL

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; Drug: induction phase2; Drug: protocol M; Drug: maintenance therapy; Drug: reinduction phase1; Drug: reinduction phase2; Drug: Intrathecal (IT)

Interventions

induction phase1 DRUG

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

Also known as: Vincristine,Pirarubicin,Prednisone,Pegaspargase

Modifed BFM-95

induction phase2 DRUG

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

Also known as: Cyclophosphamide,Cytarabine,Mercaptopurine

Modifed BFM-95

protocol M DRUG

Methotrexate: 5 g/m2 d 8, 22, 36, 50;Mercaptopurine:25 mg/m2 1-56

Also known as: Methotrexate,Mercaptopurine

Modifed BFM-95

maintenance therapy DRUG

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

Also known as: 6-mercaptopurine,Methotrexate

Modifed BFM-95

reinduction phase1 DRUG

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

Also known as: Vincristine,Pirarubicin,Prednisone,Pegaspargase

Modifed BFM-95

reinduction phase2 DRUG

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

Also known as: Cyclophosphamide,Cytarabine,Mercaptopurine

Modifed BFM-95

Intrathecal (IT) DRUG

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

Also known as: methotrexate ,cytarabine and dexamethasone

Modifed BFM-95

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related 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: 10.3109/10428194.2013.828350. Epub 2014 Mar 7.

  PMID: 24475787 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Vincristine; Cyclophosphamide; Methotrexate; Mercaptopurine; Maintenance; Injections, Spinal; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Health Care Facilities Workforce and Services; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hua Wang, MD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Wang, MD.

CONTACT

0086-02087342438; wanghua@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CN (1)