CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
Busulfan +2 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/NCT00796562
NCT00796562Phase 2Completed
CompareCT.gov

A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-mismatched Bone Marrow for Patients With Hematologic Malignancies

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Nov 24, 2008·Updated Mar 14, 2019

In Brief

A Phase 2 clinical trial evaluating Busulfan, Cyclophosphamide, and 1 other intervention for MDS and 2 related conditions. Completed, enrolled 107 participants across 2 sites.

Detailed Summary

The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease for patients with blood cancers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS, Leukemias, Lymphomas
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd., National Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2014
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 17.6 years ago

Interventions

Busulfandrug

Participant will receive Busulfan injections, 4 times a day for 4 days with dilantin prophylaxis (in patients 10 years of age or older). Busulfan levels in the blood will be measured and dose adjusted, if needed.

Cyclophosphamidedrug

Patient will receive Cy by IV once a day for 2 days.

Total body irradiationradiation

Patients will receive TBI once a day for 4 days.