CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
treosulfan +7 moredrug
Likely dose
Not stated in 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/NCT00860574
NCT00860574Phase 2Completed
CompareCT.gov

A Multi-Center Study of Conditioning With Treosulfan, Fludarabine and Escalating Doses of TBI for Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS), and Acute Lymphoblastic Leukemia (ALL)

Fred Hutchinson Cancer Center·interventional·Posted Mar 12, 2009·Updated Jun 22, 2021

In Brief

A Phase 2 clinical trial evaluating treosulfan, fludarabine phosphate, and 6 other interventions for Accelerated Phase Chronic Myelogenous Leukemia and 23 related conditions. Completed, enrolled 96 participants across 3 sites.

Detailed Summary

This phase II trial is studying how well giving treosulfan together with fludarabine phosphate and total-body irradiation followed by donor stem cell transplant works in treating patients with high-risk acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop 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 tacrolimus and methotrexate before and after transplant may stop this from happening

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAccelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2009
Enrollment StartFeb 1, 2009
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.3 years ago

Interventions

treosulfandrug

Given IV

fludarabine phosphatedrug

Given IV

total-body irradiationradiation

Low dose starting at 2Gy

peripheral blood stem cell transplantationprocedure

Given IV per institutional standard practice

tacrolimusdrug

Given IV or PO

allogeneic bone marrow transplantationprocedure

Given IV per institutional standard practice

allogeneic hematopoietic stem cell transplantationprocedure

Given IV per institutional standard practice

methotrexatedrug

Given IV