Phase 2
N=47
Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin
Stem Cell Transplantation · Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00822770 ↗Enrolled (actual)
47
Serious AEs
29.8%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor — 1; 4; 7; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plerixafor (Drug); Filgrastim (Drug); Fludarabine (Drug); Busulfan (Drug); Allogeneic blood stem cell transplant (Procedure); ATG (Thymoglobulin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor |
1; 4; 7; 4 | — |
| SECONDARY Number of Participants Alive With no Disease Progression at Time of Allo Transplant |
16; 16 | — |
| SECONDARY Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30 |
32 | — |
Summary
The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).
Eligibility Criteria
Inclusion Criteria
- Patients age >/=18 to 5% blasts in the blood or bone marrow. Patients receiving second transplants after relapse are considered in the relapse group.
- White Blood Count (CBC) /= 45 %. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- No symptomatic pulmonary disease. Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) >/= 50 % of expected, corrected for hemoglobin.
- Serum creatinine /= 1 liter.
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
- History of acute hepatitis, chronic active hepatitis or cirrhosis.
- Patients with class 3 or 4 angina (New York Heart Association (NYHA) criteria).
Data sourced from ClinicalTrials.gov (NCT00822770). 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.