CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 296 enrolled
Drug / intervention
12 Week Stanford V Chemotherapy +3 moredrug
Likely dose
12 weeks of Stanford V chemotherapy plus low-dose involved-field radiotherapy; alternatively, 4 cycles of VAMP chemotherapy ± low-dose involved-field radiotherapy; or 4-6 cycles of alternating VAMP/COP chemotherapy plus low-dose involved-field radiotherapyAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed, previously untreated Hodgkin lymphoma
  • ✓Age 21 years or younger
  • ✓Ann Arbor stage IIB-IV, or stage I-IIA with specific risk features (bulky mediastinal disease, extranodal involvement, or ≥3 nodal sites)
  • ✓Patients receiving limited emergent radiotherapy or steroids for cardiopulmonary decompensation or spinal cord compression are eligible
Key exclusion· 2
  • ✕Prior treatment for Hodgkin lymphoma
  • ✕Pregnant or lactating women

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

Search/NCT00145600
NCT00145600Phase 2Completed
CompareCT.gov

Risk-Adapted Therapy for Pediatric Hodgkin's Disease

St. Jude Children's Research Hospital·interventional·Posted Sep 5, 2005·Updated Oct 20, 2022

In Brief

A Phase 2 clinical trial evaluating 12 Week Stanford V Chemotherapy, 4 cycles of VAMP chemotherapy, and 2 other interventions for Hodgkin Lymphoma. Completed, enrolled 296 participants across 5 sites.

Detailed Summary

With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartMar 2, 2000
Primary CompletionMay 31, 2012
Study CompletionNov 5, 2021
TodayJul 2, 2026
Enrollment to primary: 12.2 yearsPosted 20.8 years ago

Interventions

12 Week Stanford V Chemotherapydrug

12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children

4 cycles of VAMP chemotherapydrug

4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.

2 alternating cycles of VAMP/COP chemotherapydrug

2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.

3 alternating cycles of VAMP/COP chemotherapydrug

3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT