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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

August 26, 2016

Study Completion Date

December 31, 2016

Conditions
Diffuse Large B Cell LymphomaPost Transplant Lymphoproliferative DisorderPrimary Mediastinal (Thymic) Large B-cell Lymphoma
Interventions
DRUG

DA-EPOCH-R for DLBCL, PTLD, AND PMBCL

"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."

DRUG

Methotrexate

"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."

DRUG

Etoposide

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.

DRUG

Doxorubicin

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.

DRUG

Vincristine

Vincristine will be given on days 1-4 of each cycle at 0.4mg/m2/day (dose based on patient height and weight).

DRUG

Rituximab

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.

DRUG

Cyclophosphamide

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.

DRUG

Prednisone

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.

DRUG

G-CSF

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.

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Baylor College of Medicine

OTHER

NCT01760226 - Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies | Biotech Hunter | Biotech Hunter