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Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies


N/A
N/A
21 Years
Open (Enrolling)
Both
Burkitt Lymphoma, Burkitt Leukemia, Diffuse Large B Cell Lymphoma, Post Transplant Lymphoproliferative Disorder, Primary Mediastinal (Thymic) Large B-cell Lymphoma

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Trial Information

Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies


The subject will need to have a variety of tests, exams, or procedures to find out if s/he
can be on the study.

The subject will also require placement of a catheter that stays in the vein for safe
administration of chemotherapy drugs.

During the study...

If all of the tests that have been done show that s/he can participate and s/he chooses to
participate, treatment cycles will begin.

For patients with Burkitt Lymphoma and B-ALL:

A cycle equals three weeks. The subject will have a minimum of 6 cycles of treatment. The
cancer drugs s/he will receive are etoposide, vincristine, doxorubicin, cyclophosphamide,
prednisone, and rituximab with each cycle. The amount of the drugs will be determined by the
subject's weight at first, and some of the drugs will be adjusted up or down for later
cycles.

After two cycles of treatment, the subject will have imaging scans to see how the cancer
responded to treatment. If the cancer responded partially or completely to treatment, s/he
will receive an additional four cycles of treatment that are dose-adjusted like before.

For subjects with DLBCL, PTLD, and PMBCL:

A cycle equals three weeks. The subject will have a minimum of 6 cycles of treatment,
possibly 8. The cancer drugs s/he will receive are etoposide, vincristine, doxorubicin,
cyclophosphamide, prednisone, and rituximab with each cycle. The amount of the drugs will be
determined by the subject's weight at first, and some of the drugs will be adjusted up or
down for later cycles.

Rituximab will be given on Day 1 prior to continuous infusion drugs.

After 4 cycles, the subject will have imaging scans again to see how the cancer responded
to treatment. If the cancer responds completely after 4 cycles, s/he will get 2 more cycles
(6 cycles total). If the cancer partially responds, s/he will get 4 more cycles (8 total
cycles).

For all subjects:

If the subject has cancer in the Central Nervous System, s/he will receive a drug called
methotrexate. If s/he does not have cancer in the CNS, s/he will get methotrexate to try to
prevent CNS cancer.


Inclusion Criteria:



- Patient with newly diagnosed, histologically confirmed, Group B or C Burkitt lymphoma
or leukemia (acute lymphoblastic leukemia, L3 subtype); diffuse large B-cell
lymphoma; or primary mediastinal B-cell lymphoma. Patients with Group B/C post
transplant lymphoproliferative disorder are eligible for the study regardless of
whether disease is newly diagnosed. (Murphy staging will be used for group
classification.)

Exclusion Criteria:

- Patient who has received previous chemotherapy or radiation therapy in the previous 3
months, except for empiric initial intrathecal administration at diagnosis. Rituximab
or steroid administration is not an exclusion criterion.

- Patient who has received any prior anthracyclines.

- Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of
significant cardiac dysfunction by echocardiogram (shortening fraction <28%) NOT due
to mediastinal mass.

- Patient with severe renal disease (i.e. creatinine greater than 3 times normal for
age; creatinine clearance less than 50 ml/min/1.73m2).

- Patient with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST
greater than 500 IU/L).

- Patient with a Karnofsky performance score <50% or Lansky score <50%.

- HIV-positive patients will be excluded unless antiretroviral therapy can be safely
withheld during chemotherapy administration, based on clinical determination of
infectious disease team evaluation.

- Female patient who is pregnant or breastfeeding.

- Patient with reproductive potential not willing to use an acceptable method of birth
control (i.e. hormonal contraception, intrauterine device, condom or diaphragm with
spermicide, or abstinence) for the duration of the study and one year post completion
of therapy.

- Patient with group classification A disease, or group classification B stage I or II
disease with normal LDH level AND tumor mass less than 7 cm.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure and assess adverse events

Outcome Description:

Adverse event data will be collected to evaluate the safety and feasibility of dose-adjusted EPOCH-R in the treatment of children with mature B-cell malignancies.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Stephen Simko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

H-30759, DA-EPOCH-R

NCT ID:

NCT01760226

Start Date:

January 2013

Completion Date:

January 2026

Related Keywords:

  • Burkitt Lymphoma
  • Burkitt Leukemia
  • Diffuse Large B Cell Lymphoma
  • Post Transplant Lymphoproliferative Disorder
  • Primary Mediastinal (Thymic) Large B-cell Lymphoma
  • B Cell lymphoma
  • lymphoma
  • Burkitt
  • DLBCL
  • Diffuse large B cell lymphoma
  • dose adjusted
  • EPOCH
  • Etoposide
  • Doxorubicin
  • Vincristine
  • Cyclophosphamide
  • Prednisone
  • Rituximab
  • Burkitt Lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorders
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Texas Children's HospitalHouston, Texas