Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2020-11-11
• Target enrollment: 0
• Participant gender: All

Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety of this treatment will also be studied. CD20 is a protein "marker" that is found in leukemia or lymphoma cells.

This is an investigational study. Liposomal vincristine is FDA approved for the treatment of patients with CLL who have relapsed at least 2 times. All of the other study drugs used in this study are FDA approved and commercially available. The combination of liposomal vincristine with the other study drugs is also being used in research only.

Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Spectrum Pharmaceuticals, Inc
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Imatinib Mesylate; Lenograstim; Liposomal doxorubicin; Mesna; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Vincristine

Criteria

Inclusion Criteria:

1. Newly diagnosed previously untreated ALL or lymphoblastic lymphoma >/= 18 years old. Allow urgent administration of cytarabine/hydrea/atra prior to starting treatment on protocol. Allow previous administration of up to one course of Hyper-CVAD and/or FDA approved TKI.

2. Zubrod performance status

3. Adequate liver function (bilirubinrenal function (creatinine

4. No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.

5. All men and women of childbearing potential who are participating in the study must agree to use effective forms of birth control throughout the duration of their treatment.

6. Adequate cardiac function as assessed clinically

Exclusion Criteria:

1. Pregnant or lactating women. Women of childbearing potential (WOCB) must have a blood or urine pregnancy test within 7 days prior to administration of the study drug. (WOCB is defined as a woman who has not undergone hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months).

2. Active Grade III-IV cardiac failure as defined by the New York Heart Association criteria, uncontrolled angina or MI within 6 months.

3. Patients with medical conditions that compromise their ability to complete the study or confound interpretation of study results.