Overview

Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning

Status:
Active, not recruiting
Trial end date:
2024-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Busulfan
Fludarabine
Fludarabine phosphate
Lenograstim
Methotrexate
Tacrolimus
Vidarabine
Criteria
Inclusion Criteria:

1. 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.

2. Patients must have a histocompatible stem cell donor. An HLA-identical related donor
or a 8/8 matched unrelated donor.

3. Age 5 to 75 years old.

4. Performance score of >/= 70 by Karnofsky/Lansky or PS 0 to 1 (ECOG
5. Left ventricular ejection fraction at least 40%.

6. Adequate pulmonary function with FEV1, FVC and DLCO >/=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

7. Creatinine clearance (calculated creatinine clearance is permitted) should be >40
ml/min.

8. Bilirubin 200.

9. 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.

10. Patient or patient's legal representative, parent(s) or guardian able to sign informed
consent.

Exclusion Criteria:

1. HIV seropositivity.

2. Uncontrolled infections.