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Burkitt Leukemia - Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Ofatumumab (EPOCH - O)

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: Ofatumumab (Drug); Etoposide (Drug); Doxorubicin (Drug); Vincristine (Drug); Cyclophosphamide (Drug); Prednisone (Drug); Rituximab (Drug); Pegfilgrastim (Drug); G-CSF (Drug); Phone Calls (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Elias Jabbour, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Elias Jabbour, MD, Phone: 713-792-4764

Summary

The goal of this clinical research study is to learn if adding ofatumumab/rituximab to the standard combination of DA-EPOCH (dose-adjusted etoposide, prednisone, vincristine, and cyclophosphamide) can help control the disease in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or relapsed/refractory ALL. The safety of this drug combination will also be studied.

Clinical Details

Official title: Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Complete Response (CR) Rate for Patients with Newly Diagnosed Burkitt Leukemia

Complete Response (CR) Rate for Patients with Relapsed/Refractory Burkitt Leukemia

Detailed description: Central Venous Catheter (CVC): If you are found to be eligible to take part in this study, you will receive a CVC if you do not already have one. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. Study Drug Administration: Each cycle lasts 21-28 days. You will receive up to 8 cycles of EPOCH in combination with ofatumumab or rituximab (EPOCH-O/R) with 2 doses of ofatumumab or rituximab each cycle for the first 4 cycles, except for Cycle 1, where you will receive 1 extra dose of ofatumumab to help prevent side effects. You may receive rituximab instead of ofatumumab if your insurance provider does not cover the cost of ofatumumab. You will receive ofatumumab by vein (over about 2 hours) on Days 1, 2, and 11 of Cycle 1. You will also receive it on Days 1 and 8 of Cycles 2 and 4, and on Days 1 and 11 of Cycle 3. If you will receive rituximab instead of ofatumumab, you will receive it by vein (over about 2 hours) on Days 1 and 11 of Cycles 1 and 3 and on Days 2 and 8 of Cycles 2 and 4. You will receive etoposide, doxorubicin, and vincristine by vein over about 24 hours each on Days 1-4 of each cycle. You will receive cyclophosphamide by vein over about 1 to 2 hours on Day 5 of each cycle. You will take prednisone by mouth 2 times a day on Days 1-5 of each cycle. You will also receive pegfilgrastim by vein within 3 days after receiving the drugs above to help prevent side effects. You may also receive filgrastim if the study doctor thinks it is needed to also help prevent side effects. If the study doctor thinks it is needed, you will receive methotrexate and cytarabine by spinal tap. The study doctor will tell you more about this. You may be able to receive the study drugs at a clinic near your home. Talk to the study doctor about this possible option. Study Visits: One (1) time a week for the first cycle, then every 2 weeks during Cycles 2-8, blood (about 2 tablespoons) will be drawn for routine tests. On Day 14, and then 1-2 weeks later, and then every 3 months for the first year, then every 6 months for the next 2 years:

- You will have a bone marrow aspiration and/or biopsy to check the status of the

disease. Length of Study: You may receive up to 8 cycles of study drugs. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. Follow-Up Visits: One (1) time every 3 months for the first year after you finish receiving the study drugs and every 6 months for the next 2 years, you will come to the clinic. The following tests and procedures will be performed:

- Blood (about 2 tablespoons) will be drawn for routine tests.

- You will have a bone marrow aspiration and/or biopsy to check the status of the

disease. Long-Term Follow-Up: The study staff will call you every 3 months for 1 year after you finish receiving the study drugs. During the calls, you will be asked how are you feeling and about any side effects you may have, and any drugs you may have taken. These calls should last about 5 minutes each time. This is an investigational study. DA-EPOCH is commercially available and FDA-approved for the treatment of Burkitt leukemia and ALL. Ofatumumab and rituximab are commercially available and FDA-approved for the treatment of some types of chronic lymphocytic leukemia (CLL). It is considered investigational to add ofatumumab to DA-EPOCH to treat Burkitt leukemia and ALL. The study doctor can explain how the study drugs are designed to work. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Burkitt's or Burkitt-like leukemia/lymphoma, either previously untreated, or relapsed/refractory, or HIV-related. Patients HIV positive will be described and reported separately or relapsed/refractory acute lymphoblastic leukemia (ALL). 2. All ages are eligible 3. Zubrod performance status

Locations and Contacts

Elias Jabbour, MD, Phone: 713-792-4764

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: January 2015
Last updated: August 6, 2015

Page last updated: August 23, 2015

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