Clinical Trial: NCT02199184 - My Cancer Genome

NCT02199184

Description:

This phase II trial studies how well a dose adjusted regimen consisting of etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH) works in combination with ofatumumab or rituximab in treating patients with Burkitt lymphoma that is newly diagnosed, or has returned after a period of improvement (relapsed), or has not responded to previous treatment (refractory) or relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab and rituximab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) together with monoclonal antibody therapy may kill more cancer cells.

Related Conditions:

Acute Lymphoblastic Leukemia
Burkitt Leukemia
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Double-Hit Lymphoma
Triple-Hit Lymphoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02199184

Trial Eligibility

Document

Title

Brief Title: Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia
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

Clinical Trial IDs

ORG STUDY ID: 2014-0123
SECONDARY ID: NCI-2014-01707
SECONDARY ID: 2014-0123
SECONDARY ID: P30CA016672
NCT ID: NCT02199184

Conditions

AIDS-Related Burkitt Lymphoma
Atypical Burkitt/Burkitt-Like Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
Recurrent Acute Lymphoblastic Leukemia
Recurrent Burkitt Lymphoma
Refractory Acute Lymphoblastic Leukemia
Refractory Burkitt Lymphoma

Interventions

Drug	Synonyms	Arms
Cyclophosphamide	(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719	Treatment (DA-EPOCH and ofatumumab or rituximab)
Doxorubicin Hydrochloride	5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex	Treatment (DA-EPOCH and ofatumumab or rituximab)
Etoposide	Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16	Treatment (DA-EPOCH and ofatumumab or rituximab)
Ofatumumab	Arzerra, GSK1841157, HuMax-CD20, HuMax-CD20, 2F2	Treatment (DA-EPOCH and ofatumumab or rituximab)
Prednisone	.delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone	Treatment (DA-EPOCH and ofatumumab or rituximab)
Rituximab	ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima	Treatment (DA-EPOCH and ofatumumab or rituximab)
Vincristine Sulfate	Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate	Treatment (DA-EPOCH and ofatumumab or rituximab)

Purpose

Detailed Description

      PRIMARY OBJECTIVE:

      I. To evaluate the clinical efficacy of the combination of dose adjusted (DA)-EPOCH +
      ofatumumab in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or
      relapsed/refractory acute lymphoblastic leukemia (ALL) defined by complete response rate.

      SECONDARY OBJECTIVE:

      I. To evaluate the safety of this combination, the overall survival and event-free survival
      rates.

      OUTLINE:

      Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride intravenously (IV),
      vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4;
      cyclophosphamide IV over 1-2 hours on day 5; and prednisone orally (PO) twice daily (BID) on
      days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1;
      on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9
      injections. Patients may receive rituximab instead of ofatumumab if their insurance provider
      does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1
      and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28
      days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 2-4 months for 1 year and
      then every 4-8 months for 2 years.

Trial Arms

Name	Type	Description	Interventions
Treatment (DA-EPOCH and ofatumumab or rituximab)	Experimental	Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Cyclophosphamide Doxorubicin Hydrochloride Etoposide Ofatumumab Prednisone Rituximab Vincristine Sulfate

Eligibility Criteria

        Inclusion Criteria:

          -  Burkitt's or Burkitt-like leukemia/lymphoma, either previously untreated, or
             relapsed/refractory, or human immunodeficiency virus (HIV)-related; patients with
             double or triple hit high-grade leukemia/lymphoma are eligible also; patients HIV
             positive will be described and reported separately or relapsed/refractory acute
             lymphoblastic leukemia (ALL).

          -  Zubrod performance status =< 3 (Eastern Cooperative Oncology Group [ECOG] scale)

          -  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)

          -  Adequate cardiac function defined as no history of clinically significant arrhythmia,
             or history of myocardial infarction (MI) within 3 months prior to study enrollment;
             cardiac function will be assessed by history and physical examination

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Active and uncontrolled disease/infection as judged by the treating physician

          -  Unable or unwilling to sign the consent form

          -  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)

Maximum Eligible Age:	N/A
Minimum Eligible Age:	N/A
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Complete response rates
Time Frame:	Up to 3 years
Safety Issue:
Description:	Will be estimated along with the 95% credible intervals.

Secondary Outcome Measures

Measure:	Incidence of adverse events
Time Frame:	Up to 3 years
Safety Issue:
Description:	Safety data will be summarized using frequency and percentage.

Measure:	Overall survival time
Time Frame:	Up to 3 years
Safety Issue:
Description:	Will be estimated using the Kaplan-Meier method.

Measure:	Event-free survival
Time Frame:	Up to 3 years
Safety Issue:
Description:	Will be estimated using the Kaplan-Meier method.

Measure:	Complete response duration
Time Frame:	Up to 3 years
Safety Issue:
Description:	Will be estimated using the Kaplan-Meier method.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	M.D. Anderson Cancer Center

Last Updated

March 24, 2020

Clinical Trials /

Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia