CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Sargramostim (GM-CSF) +1 moredrug
Likely dose
Sargramostim (GM-CSF) 250 micrograms subcutaneously × 3 doses; pneumococcal vaccine subcutaneously on Day 0AI-extracted
Key inclusion· 1
  • ✓Chronic lymphocytic leukemia (CLL) in complete or partial remission, or active CLL with Rai stage 0–4
Key exclusion· 9
  • ✕Neutropenia (PMNs <500 cells/mm³)
  • ✕Rituximab within 6 months
  • ✕Fever (temperature >38°C) within 1 week
  • ✕Active infection

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

Search/NCT00323557
NCT00323557Phase 2Completed
CompareCT.gov

Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

M.D. Anderson Cancer Center·interventional·Posted May 9, 2006·Updated Dec 5, 2012

In Brief

A Phase 2 clinical trial evaluating Sargramostim (GM-CSF) and Pneumococcal Vaccine for Leukemia. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2006
Enrollment StartJun 1, 2004
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.1 years ago

Interventions

Sargramostim (GM-CSF)drug

Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.

Pneumococcal Vaccinebiological

Subcutaneously on Day 0