At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 210 enrolled

Drug / intervention

Fludarabine Phosphate +6 moredrug

Likely dose

Fludarabine phosphate (IV) + Total-body irradiation, followed by tacrolimus (IV or PO), mycophenolate mofetil (PO), and/or sirolimus (PO) in randomized combinationsAI-extracted

Key inclusion· 10

✓Ages >50 years with hematologic malignancies treatable by unrelated HCT
✓Ages ≤50 years at high risk for transplant-related toxicity (>40% TRM risk or HCT-comorbidity index ≥1) due to pre-existing conditions or prior therapy
✓Ages ≤50 years with prior high-dose transplantation
✓Ages ≤50 years with chronic lymphocytic leukemia (CLL)

Key exclusion· 13

✕Rapidly progressive intermediate or high-grade NHL
✕CMML diagnosis
✕CNS involvement refractory to intrathecal chemotherapy
✕Circulating leukemic blasts in peripheral blood for AML, MDS, ALL, or CML

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

Search/NCT00105001

NCT00105001Phase 2Completed

Compare CT.gov

A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A Multi-Center Trial

Fred Hutchinson Cancer Center·interventional·Posted Mar 4, 2005·Updated Oct 30, 2019

In Brief

A Phase 2 clinical trial evaluating Fludarabine Phosphate, Total-Body Irradiation, and 5 other interventions for Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable and 115 related conditions. Completed, enrolled 210 participants across 11 sites in 3 countries.

Detailed Summary

This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation 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 MMF and tacrolimus with or without sirolimus after transplant may stop this from happening.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

CountriesDenmark, Germany, United States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2004

First PostedMar 2005

Primary CompletionMay 2011

Study CompletionMay 2015

TodayJul 2026

First PostedMar 4, 2005

Enrollment StartNov 1, 2004

Primary CompletionMay 1, 2011

Study CompletionMay 8, 2015

TodayJul 2, 2026

Enrollment to primary: 6.5 yearsPosted 21.3 years ago

Interventions

Fludarabine Phosphatedrug

Given IV

Total-Body Irradiationradiation

Undergo total-body irradiation

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplantation

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic peripheral blood stem cell transplantation

Tacrolimusdrug

Given IV or PO

Mycophenolate Mofetildrug

Given PO

Sirolimusdrug

Given PO