CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
busulfan +3 moredrug
Likely dose
busulfan 4 mg/kgfrom 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/NCT00612716
NCT00612716Phase 2Completed

Unrelated or Partially Matched Allogeneic Donor Stem Cells for Lymphoma, Myeloma, and Chronic Lymphocytic Leukemia

Masonic Cancer Center, University of Minnesota·interventional·Posted Feb 12, 2008·Updated Dec 9, 2020

In Brief

A Phase 2 clinical trial evaluating busulfan, cyclophosphamide, and 2 other interventions for Leukemia and 2 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving methotrexate and cyclosporine after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2008
Enrollment StartOct 6, 1999
Primary CompletionNov 15, 2019
Study CompletionDec 15, 2019
TodayJul 2, 2026
Enrollment to primary: 20.1 yearsPosted 18.4 years ago

Interventions

busulfandrug

For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.

cyclophosphamidedrug

Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.

Stem cell infusionbiological

Infused on Day 0

Total body irradiationradiation

165 cGy morning and evening on days -4 through -1.