CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Etoposide, carboplatin, ifosfamide +2 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/NCT00712582
NCT00712582Phase 2Completed

Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma

Memorial Sloan Kettering Cancer Center·interventional·Posted Jul 10, 2008·Updated Jun 21, 2022

In Brief

A Phase 2 clinical trial evaluating Etoposide, carboplatin, ifosfamide, Rituximab, Ifosfamide, Etoposide, Carboplatin, and 1 other intervention for Non-Hodgkin's Lymphoma. Completed, enrolled 96 participants across 1 site.

Detailed Summary

About 60% of patients with DLBCL can be cured with a chemotherapy program. It is called RCHOP-21 (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). It is given once every 3 weeks, for 18 weeks. Each three weeks is a cycle. Some factors predict that you may not be cured with R-CHOP-21. The most common ones are: * Stage - how much DLBCL, PMBL, or FL3B you have * LDH - a blood chemistry marker; and * Whether you can do your normal daily activities. (performance status) We think that the best way to cure more patients with poor risk factors is to add new treatment to R-CHOP. You will get different chemotherapy after 4 cycles. This type of treatment is called risk-adapted therapy.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 12, 2021
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 18.0 years ago

Interventions

Etoposide, carboplatin, ifosfamidedrug

Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.

Rituximab, Ifosfamide, Etoposide, Carboplatindrug

It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.

Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustinedrug

It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights. Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.