CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Cyclosporine +6 moredrug
Likely dose
Fludarabine IV, total-body irradiation (nonmyeloablative conditioning), cyclosporine PO, mycophenolate mofetil PO, with allogeneic peripheral blood stem cell transplantAI-extracted
Key inclusion· 6
  • Diagnosis of CLL, small lymphocytic lymphoma, CLL progressing to prolymphocytic leukemia, T-cell CLL, or PLL
  • For B-Cell CLL/PLL: failed to meet NCI response criteria after fludarabine-based therapy OR disease relapse within 12 months of completing fludarabine-based therapy
  • Failed FCR combination chemotherapy at any point
  • De novo or acquired 17p deletion cytogenetic abnormality (may be transplanted in first complete response if induction chemotherapy received)
Key exclusion· 10
  • HIV, HTLV-1, or HTLV-2 infection
  • Active CNS involvement with CLL
  • Active non-hematologic malignancies (except non-melanoma skin cancers)
  • History of non-hematologic malignancies (except non-melanoma skin cancers) not in complete remission for ≥5 years with >20% recurrence risk

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

Search/NCT00060424
NCT00060424Phase 2Completed

Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - A Multi-center Trial

Fred Hutchinson Cancer Center·interventional·Posted May 7, 2003·Updated Dec 8, 2017

In Brief

A Phase 2 clinical trial evaluating Cyclosporine, Fludarabine Phosphate, and 5 other interventions for B-Cell Prolymphocytic Leukemia and 6 related conditions. Completed, enrolled 21 participants across 3 sites in 2 countries.

Detailed Summary

This clinical trial studies how well giving fludarabine phosphate together with total-body irradiation (TBI) before donor peripheral blood stem cell transplant works in treating patients with chronic lymphocytic leukemia or small lymphocytic leukemia. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy before or after peripheral blood stem cell transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells 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 cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening.

Study Details

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2003
Enrollment StartMar 1, 2003
Primary CompletionSep 1, 2010
Study CompletionSep 22, 2010
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 23.2 years ago

Interventions

Cyclosporinedrug

Given PO

Fludarabine Phosphatedrug

Given IV

Hematopoietic Cell Transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplant

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplant

Total-Body Irradiationradiation

Undergo TBI