Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

Plain-language summary

This study evaluates an augmented Berlin-Frankfurt-Munster (BFM) chemotherapy regimen in adolescents and young adults with acute lymphoblastic leukemia or lymphoblastic lymphoma. It included patients aged 12-40 who were untreated or had at most one prior regimen. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

M.D. Anderson Cancer Center

Intervention

Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Methotrexate, Doxorubicin, Thioguanine

Start date

9/12/2006

Estimated completion

7/26/2018

Countries

United States

Related genes

Locations

• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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)