CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
KGEL vaccine +3 morebiological
Likely dose
Rituximab 375 mg/m² on Days -10, -7, and weeks 4-7; Cyclophosphamide 50 mg/kg/day on Days -3, -2, -1, 0; KGEL vaccine 1×10⁸ cells at weeks 0, 4, 8, 12, 16, 24; Filgrastim 5 mcg/kg/day from Day +6AI-extracted
Key inclusion· 4
  • ✓Histologically confirmed classical Hodgkin's lymphoma
  • ✓Relapsed disease with at least partial response or metabolic response to most recent salvage therapy
  • ✓Age 18 and over
  • ✓ECOG performance status 0-1
Key exclusion· 6
  • ✕Primary induction failure (disease progression during or within 2 months after first-line therapy completion)
  • ✕Known HIV positivity
  • ✕Active infection requiring oral or IV antibiotics
  • ✕Autoimmune or other disease requiring long-term systemic steroids or immunosuppressants

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

Search/NCT00134082
NCT00134082Phase 2Completed
CompareCT.gov

Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 24, 2005·Updated Feb 26, 2019

In Brief

A Phase 2 clinical trial evaluating KGEL vaccine, Filgrastim, and 2 other interventions for Lymphoma. Completed, enrolled 31 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2005
Enrollment StartNov 1, 2005
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.9 years ago

Interventions

KGEL vaccinebiological

Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10\^8 cells per dose. The first dose was given on Day +1.

Filgrastimbiological

5 mcg/kg/day starting on Day +6 until ANC is \>= 1000/mcL.

Rituximabbiological

375 mg/m\^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.

Cyclophosphamidedrug

50 mg/kg/day on Day -3, -2, -1, and 0.