CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
busulfan +5 moredrug
Likely dose
Busulfan 1 mg/kg/dose orally (or 40 mg/m² for young children); cyclophosphamide IV; cytarabine IV; etoposide infusion; total body irradiationAI-extracted
Key inclusion· 10
  • AML in first, second, or greater remission
  • AML in early relapse with <30% marrow blasts
  • ALL in second or greater complete remission
  • High-risk ALL in first complete remission (t(4;11), t(9;22), t(8;14), extreme hyperleukocytosis with WBC >500 K/ml, or failure to achieve CR after standard induction)
Key exclusion· 11
  • Life expectancy <3 months with therapy
  • ECOG performance status >2 or Lansky Scale <70%
  • Active infection (soft tissue, sinus, dental, fungal, or hepatitis)
  • HIV-positive

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

Search/NCT00054327
NCT00054327Phase 2Completed

Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors

Case Comprehensive Cancer Center·interventional·Posted Feb 6, 2003·Updated Jul 24, 2013

In Brief

A Phase 2 clinical trial evaluating busulfan, cyclophosphamide, and 4 other interventions for Leukemia and 3 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2003
Enrollment StartNov 1, 2000
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 23.4 years ago

Interventions

busulfandrug

Given orally 1mg/kg/dose (or 40mg/m2/dose for young children)

cyclophosphamidedrug

Given IV

cytarabinedrug

Given IV

radiation therapyradiation

Patients undergo total body irradiation

Etoposidedrug

infusion

Stem Cell Transfusionprocedure