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

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ClinicalTrials.gov Identifier: NCT02199184
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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 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.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Ofatumumab Drug: Etoposide Drug: Doxorubicin Drug: Vincristine Drug: Cyclophosphamide Drug: Prednisone Drug: Rituximab Drug: Pegfilgrastim Drug: G-CSF Behavioral: Phone Calls Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 or Relapsed/Refractory Acute Lymphoblastic Leukemia
Actual Study Start Date : January 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: Relapsed/Refractory Burkitt Leukemia Group

Ofatumumab 300 mg by vein on day 1 (before infusions) and 2,000 mg on days 2 and 11 during Cycle 1 only. Starting with Cycle 2, participants receive Ofatumumab 2,000 mg by vein on days 1 and 8 of Cycles 2 and 4, and day 1 and 11 of Cycle 3 for a total of 8 injections of ofatumumab. Etoposide 50 mg/m2/day by vein days 1- 4.

Doxorubicin 10 mg/m2/day by vein days 1-4. Vincristine 0.5 mg by vein days 1-4. Cyclophosphamide 750 mg/m2 by vein on day 5. Prednisone 60 mg by mouth twice a day on days 1-5. Rituximab 375 mg/m2 by vein on days 1 and 11 of Cycle 1 and 3 and days 2 and 8 of Cycle 2 and 4 replaces ofatumumab if insurance does not approve ofatumumab.

Pegfilgrastim (Neulasta) 6 mg within 72 hours after completion of chemotherapy. G-CSF 10 µg/kg/day until neutrophil recovery 1 x 109/L or higher can be substituted or can be added to Pegfilgrastim if neutrophils have not recovered to 1 x 109/L by day 21.

Drug: Ofatumumab
300 mg by vein on day 1 (before infusions) and 2,000 mg on days 2 and 11 during Cycle 1 only. Starting with Cycle 2, participants receive Ofatumumab 2,000 mg by vein on days 1 and 8 of Cycles 2 and 4, and day 1 and 11 of Cycle 3 for a total of 8 injections of ofatumumab. Cycles are 21 - 28 days.
Other Name: Arzerra

Drug: Etoposide
50 mg/m2/day by vein days 1- 4 of a 21 - 28 day cycle.
Other Name: VePesid

Drug: Doxorubicin
10 mg/m2/day by vein days 1 - 4 of a 21 - 28 day cycle.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Drug: Vincristine
0.5 mg by vein days 1 - 4 of a 21 - 28 day cycle.

Drug: Cyclophosphamide
750 mg/m2 by vein on day 5 of a 21 - 28 day cycle.
Other Names:
  • Cytoxan
  • Neosar

Drug: Prednisone
60 mg by mouth twice a day on days 1 - 5 of a 21 - 28 day cycle.

Drug: Rituximab
375 mg/m2 by vein on days 1 and 11 of Cycle 1 and 3 and days 2 and 8 of Cycle 2 and 4 of a 21 - 28 day cycle. Rituximab replaces ofatumumab if insurance does not approve ofatumumab.
Other Name: Rituxan

Drug: Pegfilgrastim
6 mg within 72 hours after completion of chemotherapy.
Other Names:
  • Neulasta
  • PEG-G-CSF

Drug: G-CSF
10 µg/kg/day until neutrophil recovery 1 x 109/L or higher, can be substituted or can be added to Pegfilgrastim if neutrophils have not recovered to 1 x 109/L by day 21.
Other Names:
  • Filgrastim
  • Neupogen

Behavioral: Phone Calls
Participant receives phone calls from study staff every 3 months for 1 year after receiving the study drugs. These calls should last about 5 minutes each time.

Experimental: Newly Diagnosed Burkitt Leukemia Group

Ofatumumab 300 mg by vein on day 1 (before infusions) and 2,000 mg on days 2 and 11 during Cycle 1 only. Starting with Cycle 2, participants receive Ofatumumab 2,000 mg by vein on days 1 and 8 of Cycles 2 and 4, and day 1 and 11 of Cycle 3 for a total of 8 injections of ofatumumab. Etoposide 50 mg/m2/day by vein days 1- 4.

Doxorubicin 10 mg/m2/day by vein days 1-4. Vincristine 0.5 mg by vein days 1-4. Cyclophosphamide 750 mg/m2 by vein on day 5. Prednisone 60 mg by mouth twice a day on days 1-5. Rituximab 375 mg/m2 by vein on days 1 and 11 of Cycle 1 and 3 and days 2 and 8 of Cycle 2 and 4 replaces ofatumumab if insurance does not approve ofatumumab.

Pegfilgrastim (Neulasta) 6 mg within 72 hours after completion of chemotherapy. G-CSF 10 µg/kg/day until neutrophil recovery 1 x 109/L or higher can be substituted or can be added to Pegfilgrastim if neutrophils have not recovered to 1 x 109/L by day 21.

Drug: Ofatumumab
300 mg by vein on day 1 (before infusions) and 2,000 mg on days 2 and 11 during Cycle 1 only. Starting with Cycle 2, participants receive Ofatumumab 2,000 mg by vein on days 1 and 8 of Cycles 2 and 4, and day 1 and 11 of Cycle 3 for a total of 8 injections of ofatumumab. Cycles are 21 - 28 days.
Other Name: Arzerra

Drug: Etoposide
50 mg/m2/day by vein days 1- 4 of a 21 - 28 day cycle.
Other Name: VePesid

Drug: Doxorubicin
10 mg/m2/day by vein days 1 - 4 of a 21 - 28 day cycle.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Drug: Vincristine
0.5 mg by vein days 1 - 4 of a 21 - 28 day cycle.

Drug: Cyclophosphamide
750 mg/m2 by vein on day 5 of a 21 - 28 day cycle.
Other Names:
  • Cytoxan
  • Neosar

Drug: Prednisone
60 mg by mouth twice a day on days 1 - 5 of a 21 - 28 day cycle.

Drug: Rituximab
375 mg/m2 by vein on days 1 and 11 of Cycle 1 and 3 and days 2 and 8 of Cycle 2 and 4 of a 21 - 28 day cycle. Rituximab replaces ofatumumab if insurance does not approve ofatumumab.
Other Name: Rituxan

Drug: Pegfilgrastim
6 mg within 72 hours after completion of chemotherapy.
Other Names:
  • Neulasta
  • PEG-G-CSF

Drug: G-CSF
10 µg/kg/day until neutrophil recovery 1 x 109/L or higher, can be substituted or can be added to Pegfilgrastim if neutrophils have not recovered to 1 x 109/L by day 21.
Other Names:
  • Filgrastim
  • Neupogen

Behavioral: Phone Calls
Participant receives phone calls from study staff every 3 months for 1 year after receiving the study drugs. These calls should last about 5 minutes each time.




Primary Outcome Measures :
  1. Complete Response (CR) Rate for Patients with Newly Diagnosed Burkitt Leukemia [ Time Frame: After 2, 28 day cycles ]
    Up to 30 newly diagnosed patients enrolled in this cohort. Proposed combination study expected to achieve a CR rate of 87%, an increase of 14% in CR rate over the standard therapy. If 22 (73%) patients observed have CR, then the 95% confidence interval for CR rate is (57.1%, 88.9%). If 26 (87%) patients observed have CR, the 95% confidence interval for the CR rate will be (75%, 99%). If at any time during study there is 95% or more chance that the CR rate is less likely to improve by 14% than that under the standard treatment, study terminated in this cohort. All patients who receive at least 1 dose of the combination treatment included in the intent-to-treat analysis for efficacy and safety.

  2. Complete Response (CR) Rate for Patients with Relapsed/Refractory Burkitt Leukemia [ Time Frame: After 2, 28 day cycles ]
    10 relapsed/refractory patients enrolled. Complete response rates estimated along with the 95% credible intervals. Overall survival time, event-free survival (EFS) and complete response duration (CRD) estimated using the Kaplan-Meier method. Enrollment stopped in this cohort if Pr(TE > 0.30 | data) > 0.85. Corresponding stopping boundaries are: stop the enrollment if the Num. of patients with toxicity observed / number of patients evaluated ≥ 3/5, 4/6-7, 5/8-9. All patients who receive at least 1 dose of the combination treatment included in the intent-to-treat analysis for efficacy and safety.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </= 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199184


Contacts
Contact: Elias Jabbour, MD 713-792-4764

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Elias Jabbour, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02199184     History of Changes
Other Study ID Numbers: 2014-0123
NCI-2014-01707 ( Registry Identifier: NCI CTRP )
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Burkitt leukemia
Burkitt-like leukemia/lymphoma
Newly diagnosed
Relapsed/refractory
Ofatumumab
Arzerra
Etoposide
VePesid
Doxorubicin
Doxorubicin Hydrochloride
Adriamycin PFS
Adriamycin RDF
Adriamycin
Rubex
Vincristine
Cyclophosphamide
Cytoxan
Neosar
Prednisone
Rituximab
Rituxan
DA-EPOCH
Pegfilgrastim
Neulasta
PEG-G-CSF
G-CSF
Filgrastim
Neupogen
Phone calls

Additional relevant MeSH terms:
Leukemia
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Etoposide phosphate
Ofatumumab
Doxorubicin
Prednisone
Etoposide
Vincristine
Lenograstim
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs