CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 142 enrolled
Drug / intervention
Busulfan +1 moredrug
Likely dose
Busulfan 4 mg/kg PO daily (Days -7 to -4) or 3.2 mg/kg IV daily or 160 mg/m² daily (pediatric); Cyclophosphamide 50 mg/kg IV daily (Days -3, -2, +3, +4)AI-extracted
Key inclusion· 13
  • Diagnosis of AML beyond first complete remission (CR1)
  • Refractory AML or AML arising from myelodysplastic syndromes
  • MDS with refractory anemia and excess blasts >10% in bone marrow
  • ALL in CR1 with high-risk features (Ph-positive, age <1 year at diagnosis, or 11q23 abnormalities)
Key exclusion· 1
  • Not pregnant or nursing; negative pregnancy test required

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

Search/NCT00134017
NCT00134017Phase 2Completed

HLA Matched Related and Unrelated Bone Marrow Transplantation With Busulfan/Cyclophosphamide and Post Transplantation Cyclophosphamide for Hematological Malignancies

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 24, 2005·Updated Aug 31, 2018

In Brief

A Phase 2 clinical trial evaluating Busulfan and Cyclophosphamide for Chronic Myeloproliferative Disorders and 4 related conditions. Completed, enrolled 142 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy before a donor bone marrow 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 healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2005
Enrollment StartJun 1, 2004
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.9 years ago

Interventions

Busulfandrug

Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m\^2 daily (for pediatric recipients)

Cyclophosphamidedrug

Days -3, -2, +3, +4: 50 mg/kg IV daily