Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT01760226
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma
  • Post Transplant Lymphoproliferative Disorder
  • Primary Mediastinal (Thymic) Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • DA-EPOCH-R for DLBCL, PTLD, AND PMBCL — DRUG
    Day 1: Rituximab IV Days 1-4: After rituximab, etoposide, vincristine, and doxorubicin will be given in a vein over 96 hours as a continuous infusion. Day 5: cyclophosphamide will be given in a vein Days 1-5: prednisone given by mouth twice a day G-CSF 5mcg/kg/day will be given under the skin from day 6 until ANC has improved.
  • Methotrexate — DRUG
    CNS negative patients with high CNS risk DLBCL will receive age based, intrathecal dosing of MTX on days 1 and 5 of cycles 3 - 6 only. CNS positive patients will receive age based, intrathecal (within the spinal fluid) MTX twice weekly for 2 weeks past the first negative cytology with a minimum of 4 weeks treatment. Then, weekly for 6 weeks and then every 4 weeks for 6 months. DLBCL/PTLD/PMBCL CNS prophylaxis for cycles 3-6 ONLY if: * 2+ extranodal sites * elevated LDH, * MYC rearrangement OR * bone or marrow disease. ALL OTHERS receive IT MTX cycles 3-6.
  • Etoposide — DRUG
    Etoposide will be given at 50mg/m2/day on days 1-4 of the first cycle of therapy (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
  • Doxorubicin — DRUG
    Doxorubicin will be given at 10mg/m2/day on days 1-4 of the first cycle (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
  • Vincristine — DRUG
    Vincristine will be given on days 1-4 of each cycle at 0.4mg/m2/day (dose based on patient height and weight).
  • Rituximab — DRUG
    Rituximab (375mg/m2/dose) will only be given on Day 1 of each cycle prior to all the other chemotherapy agents. Dose is based on patient height and weight.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be given on Day 5 of each cycle. In cycle 1, the dose will be 750 mg/m2 (based on patient height and weight), and the dose will be adjusted up or down for future cycles based on blood test results.
  • Prednisone — DRUG
    Prednisone will be given by mouth at 60mg/m2/dose (based on height and weight) twice a day on days 1-5 of each cycle.
  • G-CSF — DRUG
    G-CSF will be given at 5 mcg/kg/day during each cycle, starting on day 6, until the patient's ANC (absolute neutrophil count) is greater than 5000/mcL past nadir.

Study Details

The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.

Key Dates

Start date
Jan 31, 2013
Status verified
Feb 2024
Primary completion
Aug 26, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DA-EPOCH-R for DLBCL, PTLD & PMBCL
    Minimum of 6 cycles (cycle=3 weeks), possibly 8. Dosages of the drugs will be determined by the subject's weight and height for cycle 1. Thereafter, the dosages of some drugs will be adjusted up or down for the next cycle, dependent on the blood tests results. DA-EPOCH-R for 2 cycles then two more cycles of DA-EPOCH-R. If complete response (CR), then DA-EPOCH-R for more 2 cycles. If no CR, DA-EPOCH-R for 4 more cycles.

Primary Outcome Measure

Measure and assess adverse events [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's HospitalHoustonTexas77030-

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By research site
Texas Children's Hospital· Houston, TX

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