Burkitt Leukemia - Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Ofatumumab (EPOCH - O)
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/21/2019 |
Start Date: | January 2015 |
End Date: | December 31, 2022 |
Contact: | Elias Jabbour, MD |
Phone: | 713-792-4764 |
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 or Relapsed/Refractory Acute Lymphoblastic Leukemia
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 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.
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.
participant.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 = 3 (ECOG Scale, Appendix E)
4. Adequate organ function with creatinine less than or equal to 2.0 mg/dL (unless
considered tumor related), bilirubin less than or equal to 2.0 mg/dL (unless
considered tumor related).
5. Adequate cardiac function defined as no history of clinically significant arrhythmia,
or history of MI within 3 months prior to study enrollment. Cardiac function will be
assessed by history and physical examination.
Exclusion Criteria:
1. Pregnant or nursing women.
2. Active and uncontrolled disease/infection as judged by the treating physician
3. Unable or unwilling to sign the consent form
4. Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
chronic liver disease per investigator assessment)
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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