CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 enrolled
Drug / intervention
Fludarabine Phosphate +4 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Patients ineligible for conventional allogeneic HCT with disease expected to be stable for at least 100 days without chemotherapy
  • ✓HLA-matched related donor (HLA genotypically identical at least at one haplotype, phenotypically or genotypically identical at allele level at HLA-A, -B, -C, -DRB1, -DQB1)
  • ✓Hematologic malignancy (NHL, CLL, HL, CML, AML, ALL, MM, MDS/MPD, Waldenströms) meeting disease-specific criteria
  • ✓AML and ALL must have <5% marrow blasts and be beyond first CR
Key exclusion· 11
  • ✕Eligible for high-priority curative autologous transplant
  • ✕Circulating leukemic blasts in peripheral blood for AML, ALL, or CML
  • ✕CNS involvement with disease refractory to intrathecal chemotherapy
  • ✕Karnofsky score <50 (adults); Lansky-Play score <50 (pediatrics)

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

Search/NCT00075478
NCT00075478Phase 3Completed
CompareCT.gov

A Multi-center Phase III Study Comparing Nonmyeloablative Conditioning With TBI Versus Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies

Fred Hutchinson Cancer Center·interventional·Posted Jan 12, 2004·Updated May 15, 2017

In Brief

A Phase 3 clinical trial evaluating Total-Body Irradiation, Fludarabine Phosphate, and 3 other interventions for Acute Lymphoblastic Leukemia in Remission and 12 related conditions. Completed, enrolled 87 participants across 10 sites in 3 countries.

Detailed Summary

This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and radiation therapy 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 may replace the patient's immune system 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 after transplant may stop this from happening. It is not yet known whether TBI followed by donor stem cell transplant is more effective with or without fludarabine phosphate in treating hematologic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Aggressive Non-Hodgkin Lymphoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Diffuse Large B-Cell Lymphoma, Hematopoietic and Lymphoid Cell Neoplasm, Indolent Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Myelodysplastic/Myeloproliferative Neoplasm, Plasma Cell Myeloma, Refractory Chronic Lymphocytic Leukemia, Refractory Hodgkin Lymphoma, Waldenstrom Macroglobulinemia
CountriesGermany, Italy, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 12, 2004
Enrollment StartOct 1, 2003
Primary CompletionFeb 1, 2014
Study CompletionFeb 2, 2014
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 22.5 years ago

Interventions

Total-Body Irradiationprocedure

Undergo TBI

Fludarabine Phosphatedrug

Given IV

Mycophenolate Mofetildrug

Given PO

Cyclosporinedrug

Given PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo transplantation