CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Gemcitabine +4 moredrug
Likely dose
Gemcitabine 2775 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/NCT01200329
NCT01200329Phase 2Completed
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High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease

M.D. Anderson Cancer Center·interventional·Posted Sep 13, 2010·Updated Dec 16, 2019

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Busulfan, and 3 other interventions for Lymphoma. Completed, enrolled 81 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2010
Enrollment StartJun 1, 2011
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 15.8 years ago

Interventions

Gemcitabinedrug

2775 mg/m2 by vein over about 3 hours on days -8 and -3.

Busulfandrug

32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient AUC 4,000 by vein over about 3 hours on days -8 to -5.

Melphalandrug

60 mg/m2 by vein over about 30 minutes on days -3 and -2.

Stem Cell Transplantationprocedure

Infusion of stem cells on Day 0.

Palifermindrug

60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.