CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
carmustine +5 moredrug
Likely dose
Carmustine 150 mg/m² IV, cyclophosphamide 100 mg/kg IV, etoposide 60 mg/kg IV, melphalan 150 mg/m² IV, total body irradiation 150 cGy, followed by autologous stem cell transplantation (2.0 × 10⁶ CD34+ cells)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed Hodgkin's lymphoma with relapsed or refractory disease
  • ✓Biopsy or radiological evidence of disease at time of recurrence/progression required
  • ✓Has received ≥1 prior systemic chemotherapy regimen
  • ✓Patients who relapse after complete remission must complete minimum 2 courses of salvage chemotherapy or radiation to determine salvage sensitivity
Key exclusion· 6
  • ✕No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease-free >5 years)
  • ✕Central nervous system (CNS) involvement excluded
  • ✕No clonal abnormalities in marrow collection
  • ✕No other malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer

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

Search/NCT00233987
NCT00233987Phase 2Completed
CompareCT.gov

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II

SWOG Cancer Research Network·interventional·Posted Oct 6, 2005·Updated Mar 1, 2018

In Brief

A Phase 2 clinical trial evaluating carmustine, cyclophosphamide, and 4 other interventions for Lymphoma. Completed, enrolled 98 participants across 53 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartOct 1, 2005
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 20.7 years ago

Interventions

carmustinedrug

150 mg/m\^2 IV over 2 hours 4, 5, and 6 days before transplant.

cyclophosphamidedrug

100 mg/kg IV 2 days before transplant.

etoposidedrug

60 mg/kg IV over 4 hours 4 days before transplant.

melphalandrug

150 mg/m\^2 IV 1 day before transplant.

autologous-autologous tandem hematopoietic stem cell transplantationprocedure

2.0 x 10\^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.

radiation therapyradiation

150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.