CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Melphalan +5 moredrug
Likely dose
Ara-C 200 mg/m2from 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/NCT01702961
NCT01702961N/ACompleted

A Current Practice Study of Rituxan in Patient Receiving BEAM Chemotherapy and Autologous Blood Stem Cell Transplantation for High Risk Lymphoma or Hodgkin's Disease

Baylor College of Medicine·interventional·Posted Oct 10, 2012·Updated Dec 19, 2018

In Brief

A clinical study evaluating Melphalan, Ara-C, and 4 other interventions for Lymphoma and Hodgkin's Disease. Completed, enrolled 75 participants across 2 sites.

Detailed Summary

High-dose chemotherapy followed by autologous (the patient's own) peripheral blood (circulating blood) stem cell (cells that divide to form white cells, red cells and cells that help clot) transplantation is a conventional treatment for patients with lymphoma (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse (recurrence of disease). For patients who did not have a complete response after traditional chemotherapy, the chance is high that the tumor will return even after high-dose chemotherapy. To improve the response and decrease the chance of relapse, doctors have used rituximab, an antibody that kills lymphoma cells, both before and after transplantation. These doctors have reported that more patients had control of the tumor for an extended period of time using rituximab with high-dose chemotherapy with autologous stem cell transplantation. How widely this is applicable is not known. The purpose of this clinical research trial is to confirm that there is a good control of tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional stem cell transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2012
Enrollment StartJun 1, 2002
Primary CompletionAug 1, 2014
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 12.2 yearsPosted 13.7 years ago

Interventions

Melphalandrug

Given on Day -1 Melphalan is administered according to the current SOP.

Ara-Cdrug

200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16drug

200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNUdrug

BCNU 300 mg/m2 IV given on Day -6

Rituxandrug

375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cellsdrug

Stem cells given on Day 0