CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Cyclophosphamide +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02199184
NCT02199184Phase 2Completed

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

M.D. Anderson Cancer Center·interventional·Posted Jul 24, 2014·Updated Jun 11, 2024

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Doxorubicin Hydrochloride, and 5 other interventions for AIDS-Related Burkitt Lymphoma and 7 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 24, 2014
Enrollment StartJan 14, 2015
Primary CompletionFeb 17, 2023
TodayJul 1, 2026
Enrollment to primary: 8.1 yearsPosted 11.9 years ago

Interventions

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Ofatumumabbiological

Given IV

Prednisonedrug

Given PO

Rituximabbiological

Given IV

Vincristine Sulfatedrug

Given IV