Phase 2
N=201
Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning
Leukemia · Acute Myeloid Leukemia · Acute Lymphocytic Leukemia · Chronic Myeloid Leukemia · Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01572662 ↗Enrolled (actual)
201
Serious AEs
7.0%
Results posted
Jun 2023
Primary outcome: Primary: Non-Relapse Mortality Rate (NRM) — 2; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine monophosphate (Drug); Busulfan (Drug); Stem Cell Infusion (Procedure); Tacrolimus (Drug); Methotrexate (Drug); G-CSF (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-Relapse Mortality Rate (NRM) |
2; 8 | — |
| SECONDARY Overall Survival |
16; 47 | — |
| SECONDARY Overall Survival |
16; 47 | — |
Summary
The goal of this clinical research study is to learn if giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant.
The safety of this combination therapy will also be studied.
Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.
Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.
Eligibility Criteria
Inclusion Criteria
- Patients with high-risk hematologic malignancies with anticipated poor prognosis with non transplant therapy, including those in remission or with induction failure and after treated or untreated relapse. Diagnoses to be included a) Acute myeloid leukemia; b) Acute lymphocytic leukemia; c) Chronic myeloid leukemia; d) Chronic lymphocytic leukemia; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkins lymphoma; h) Hodgkins Lymphoma; i) Multiple myeloma.
- Patients must have a histocompatible stem cell donor. An HLA-identical related donor or a 8/8 matched unrelated donor.
- Age 5 to 75 years old.
- Performance score of >/= 70 by Karnofsky/Lansky or PS 0 to 1 (ECOG /=50% of expected corrected for hemoglobin and/or volume. Children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >/= 92% on room air
- Creatinine clearance (calculated creatinine clearance is permitted) should be >40 ml/min.
- Bilirubin </= 2 x the upper limit of normal (except Gilbert's Syndrome). SGPT (ALT) < 200.
- Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Exclusion Criteria
- HIV seropositivity.
- Uncontrolled infections.
Data sourced from ClinicalTrials.gov (NCT01572662). 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.