CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
carmustine +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00559104
NCT00559104Phase 2Completed

High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma

City of Hope Medical Center·interventional·Posted Nov 16, 2007·Updated Aug 11, 2015

In Brief

A Phase 2 clinical trial evaluating carmustine, cyclophosphamide, and 5 other interventions for Lymphoma. Completed, enrolled 60 participants across 2 sites.

Detailed Summary

RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2007
Enrollment StartOct 1, 1998
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 12.8 yearsPosted 18.6 years ago

Interventions

carmustinedrug

Unique to the Carmustine in Conditioning arm

cyclophosphamidedrug

Used in Both Arms

etoposidedrug

Used in Both Arms

autologous hematopoietic stem cell transplantationprocedure

Both arms are given autologous stem cell transplantation

peripheral blood stem cell transplantationprocedure

Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).

total-body irradiationradiation

Unique to the Radiation in Conditioning Arm

G-CSFdrug

G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.