At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 150 enrolled

Drug / intervention

fludarabine phosphate +6 moredrug

Likely dose

Not stated in record

Key inclusion· 6

✓Patient must be not eligible for conventional allogeneic hematopoietic cell transplantation (HCT) and must have disease expected to be stable for at least 100 days without chemotherapy
✓AML: must have <5% marrow blasts at time of transplant
✓ALL: must have <5% marrow blasts at time of transplant
✓CML: accepted beyond first chronic phase (CP1) if received previous myelosuppressive chemotherapy or HCT, and have <5% marrow blasts at time of transplant

Key exclusion· 8

✕Eligible for high priority curative autologous transplant
✕Presence of circulating leukemic blasts in peripheral blood for patients with AML, ALL, or CML
✕Life expectancy severely limited by diseases other than malignancy
✕Any current CNS involvement with disease refractory to intrathecal chemotherapy

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

Search/NCT00089011

NCT00089011Phase 2Completed

Compare CT.gov

A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil

Fred Hutchinson Cancer Center·interventional·Posted Aug 5, 2004·Updated Jan 29, 2020

In Brief

A Phase 2 clinical trial evaluating fludarabine phosphate, total-body irradiation, and 5 other interventions for Accelerated Phase Chronic Myelogenous Leukemia and 173 related conditions. Completed, enrolled 150 participants across 5 sites in 2 countries.

Detailed Summary

This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer. 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. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

CountriesItaly, United States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2004

First PostedAug 2004

Primary CompletionMar 2014

Study CompletionJul 2018

TodayJul 2026

First PostedAug 5, 2004

Enrollment StartApr 1, 2004

Primary CompletionMar 1, 2014

Study CompletionJul 1, 2018

TodayJul 2, 2026

Enrollment to primary: 9.9 yearsPosted 21.9 years ago

Interventions

fludarabine phosphatedrug

Given IV

total-body irradiationradiation

Undergo radiotherapy

mycophenolate mofetildrug

Given IV or PO

tacrolimusdrug

Given IV or PO

peripheral blood stem cell transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplant

nonmyeloablative allogeneic hematopoietic stem cell transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplant

laboratory biomarker analysisother

Correlative studies