Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

• Status: Terminated
• Trial end date: 2017-06-22
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if a chemotherapy combination called augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab, can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety of these drug combinations will also be studied.

Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG asparaginase, and methotrexate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Jazz Pharmaceuticals
• Treatments: 6-Mercaptopurine; Antibodies, Monoclonal; Asparaginase; BB 1101; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Ofatumumab; Pegaspargase; Prednisone; Rituximab; Thioguanine; Vincristine

Criteria

Inclusion Criteria:

1. Patients must have precursor-B lymphoblastic leukemia or 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 30 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 7 days 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 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.

11. Lymphoblasts may have any positive expression of cluster of differentiation antigen 20 (CD20) for ofatumumab administration.

Exclusion Criteria:

1. Age less than twelve years of age or greater than 30 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)

5. Laboratory or clinical evidence of active infectious hepatitis.