Phase 2
N=96
Safety Study of Bone Marrow Transplant Using Mismatched Tissue Followed by Chemotherapy
MDS · Leukemias · Lymphomas
Bottom Line
View on ClinicalTrials.gov: NCT00796562 ↗Enrolled (actual)
96
Serious AEs
22.9%
Results posted
Mar 2019
Primary outcome: Primary: Engraftment as Measured by Donor Chimerism — 91 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Busulfan (Drug); Cyclophosphamide (Drug); Total body irradiation (Radiation)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Engraftment as Measured by Donor Chimerism |
91 | — |
| SECONDARY Non-relapse Mortality |
10; 10 | — |
| SECONDARY Acute GVHD |
11; 4 | — |
| SECONDARY Chronic GVHD |
4; 15 | — |
| SECONDARY Survival |
73; 57; 54; 58; 52; 50 | — |
| SECONDARY Relapse |
35; 43 | — |
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
Eligibility Criteria
Inclusion Criteria
- Acute lymphocytic leukemia in high risk CR1
- Acute myeloid leukemia in CR1
- Therapy-related AML
- RAEB with >5% and 2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)
- Poor renal function: Creatinine >2.0mg/dl or creatinine clearance
- HIV-positive
- Positive leukocytotoxic crossmatch
- Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- Uncontrolled viral, bacterial, or fungal infections Patients with symptoms consistent with RSV, influenza A, B, or parainfluenza at the time of enrollment will be assayed for the above viruses and if positive are not eligible for the trial until they are no longer symptomatic (patients may have continued assay positivity for a period of time post resolution of symptoms secondary to the nature of the assay.
- Indolent lymphomas (Follicular Grade 1 and 2, marginal zone, chronic lymphocytic leukemia, small lymphocytic lymphoma, MALT)
Data sourced from ClinicalTrials.gov (NCT00796562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.