Clinical trial · Interventional
Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: A. Primary objective: 1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). B. Secondary objective: 1. To evaluate the prognostic significance of minimal residual disease in bone marrow samples at the end of induction and at the end of consolidation in this group of patients. 2. To prospectively evaluate gene hypermethylation status in this group of patients. 3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Intrathecal Methotrexate | Drug | — | UNRESOLVED |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| PEG-asparaginase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Augmented BFM Therapy
- description
- Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine
- interventionNames
- Drug: Daunorubicin
- Drug: Vincristine
- Drug: PEG-asparaginase
- Drug: Intrathecal Methotrexate
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Doxorubicin
- Drug: Thioguanine
Primary outcomes (3)
- measure
- 3-Year Event-Free Survival (EFS)
- timeFrame
- 3 Years
- description
- 3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have precursor-B or T-lymphoblastic leukemia or lymphoblastic lymphoma. 2. Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL . Previously treated patients will be analyzed separately. 3. Age between 12 to 40 years old 4. Patients with Central Nervous System (CNS) disease or testicular disease are eligible. 5. Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of the first intrathecal treatment. 6. Signed informed consent prior to the start of systemic therapy. In the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed. 7. Echocardiogram should be done within 72 hours of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction) 8. Creatinine should be \< 3 mg/dL bilirubin \< 3 mg/dl unless felt to be due to disease 9. Zubrod Performance status of \<3 10. Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately Exclusion Criteria: 1. Age less than twelve years of age or greater than 40 years. 2. More than one prior treatment regimen for ALL or LL. 3. The patient is pregnant or unwilling to practice appropriate birth control. 4. Presence of the Philadelphia chromosome t(9;22)
References
Publications (0)
Data not yet available