CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
gemcitabine hydrochloride +3 moredrug
Likely dose
Gemcitabine, carboplatin, and dexamethasone given IV/PO with rituximab IV (dose not specified in interventions)AI-extracted
Key inclusion· 8
  • Relapsed or primary refractory lymphoid malignancy (B-cell, T-cell, or Hodgkin's disease)
  • Measurable disease: lesions ≥1 cm greatest transverse diameter by imaging or ≥2 cm palpable lesions
  • Bone marrow aspirate and biopsy within 28 days of enrollment with no intervening anticancer therapy
  • CT chest, abdomen, pelvis within 28 days; CT neck if adenopathy present
Key exclusion· 6
  • HIV positive
  • Pregnant or nursing women; women of reproductive potential must use effective contraception
  • Prior malignancies except adequately treated basal/squamous cell skin cancer, cervical carcinoma in situ, or disease-free >5 years (unless PI approval)
  • Refractory to prior carboplatin/cisplatin-based or gemcitabine-based regimen (no response or progression within 6 months)

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

Search/NCT00072514
NCT00072514Phase 2Completed

A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

Fred Hutchinson Cancer Center·interventional·Posted Nov 5, 2003·Updated Jun 29, 2017

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride, carboplatin, and 2 other interventions for Adult Nasal Type Extranodal NK/T-cell Lymphoma and 30 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving more than one drug (combination chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells

Study Details

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 5, 2003
Enrollment StartAug 1, 2003
Primary CompletionJul 1, 2008
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 22.7 years ago

Interventions

gemcitabine hydrochloridedrug

Given IV

carboplatindrug

Given IV

dexamethasonedrug

Given PO

rituximabbiological

Given IV in CD20-POSITIVE LYMPHOMAS cases