CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
fludarabine +2 moredrug
Likely dose
Fludarabine 30 mg/m² IV daily for 5 days plus treosulfan 12 or 14 g/m² IV daily for 5 daysAI-extracted
Key inclusion· 8
  • ✓Diagnosis of acute myeloid leukemia, lymphoblastic leukemia, or myelodysplastic syndrome in any phase (remission, relapsed, or primary refractory)
  • ✓Planning to undergo unmanipulated allogeneic bone marrow or peripheral blood stem cell transplantation
  • ✓HLA-identical related donor OR HLA-A, -B, -C, -DRB1, and -DQB1 matched unrelated donor by high-resolution DNA typing (single allele mismatch allowed)
  • ✓Karnofsky performance status 70-100% or Lansky 70-100%
Key exclusion· 7
  • ✕CNS leukemic involvement not cleared with prior intrathecal chemotherapy and/or cranial radiotherapy
  • ✕Prior allogeneic bone marrow or stem cell transplantation
  • ✕Concurrent umbilical cord blood or autologous transplantation
  • ✕Cardiac insufficiency requiring treatment or symptomatic coronary artery disease

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

Search/NCT00253513
NCT00253513Phase 2Completed
CompareCT.gov

A Study of a Reduced-Intensity Conditioning Regimen With Treosulfan and Fludarabine for Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Leukemia

OHSU Knight Cancer Institute·interventional·Posted Nov 15, 2005·Updated Jun 1, 2012

In Brief

A Phase 2 clinical trial evaluating fludarabine, treosulfan, and 1 other intervention for Leukemia and Myelodysplastic Syndromes. Completed, enrolled 60 participants across 3 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelodysplastic Syndromes
CountriesUnited States
Collaboratorsmedac GmbH, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartJun 1, 2005
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.6 years ago

Interventions

fludarabinedrug

30 mg/m2, IV for 5 days

treosulfandrug

12 or 14 g/m2, IV for 5 days

allogeneic blood or bone marrow transplantationprocedure

bone marrow or peripheral blood stem cells