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Lymphoma, LymphoblasticPhase 2NCT02396043

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

A Phase 2 study testing induction phase1, induction phase2 and protocol M in people with Lymphoma, Lymphoblastic, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lymphoma, Lymphoblastic
What is being tested?
induction phase1, induction phase2 and protocol M
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Mar 2015to Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hua Wang, MD. contact

0086-02087342438

wanghua@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhongjun Xia, MD., 0086-02087342438, zhongjunxia_64@sina.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
induction phase1, induction phase2, protocol M, maintenance therapy, reinduction phase1
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • induction phase1Drug

    Also called Vincristine,Pirarubicin,Prednisone,Pegaspargase

    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 phase2Drug

    Also called Cyclophosphamide,Cytarabine,Mercaptopurine

    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 MDrug

    Also called Methotrexate,Mercaptopurine

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

  • maintenance therapyDrug

    Also called 6-mercaptopurine,Methotrexate

    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 phase1Drug

    Also called Vincristine,Pirarubicin,Prednisone,Pegaspargase

    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 phase2Drug

    Also called Cyclophosphamide,Cytarabine,Mercaptopurine

    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)Drug

    Also called methotrexate ,cytarabine and dexamethasone

    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

Study groups in NCT02396043
Study groupRoleWhat they receive
Modifed BFM-95ExperimentalAll 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.
Receives: Drug: induction phase1; Drug: induction phase2; Drug: protocol M; Drug: maintenance therapy; Drug: reinduction phase1; Drug: reinduction phase2; Drug: Intrathecal (IT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

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

Secondary outcomes (3)

  1. complete remission rate

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

  2. overall survival

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

  3. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02396043
Sponsor's protocol ID
LBL-308
Status last verified
Jun 2023
First submitted
18 Mar 2015
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24475787

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing induction phase1, induction phase2 and protocol M in people with Lymphoma, Lymphoblastic, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hua Wang, MD. (0086-02087342438, wanghua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: up to end of follow-up-phase (approximately 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02396043, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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