Timed Sequential Busulfan and Post Transplant Cyclophosphamide for Allogeneic Transplantation

Overview

The goal of this clinical research study is to learn if busulfan with cyclophosphamide (when given with other helper drugs listed below) can help control the diseases listed above when given before a stem cell transplant. The safety of these study drug combinations will also be studied.

SparkCures ID 827
Trial Phase Phase 2
Enrollment 100 Patients
Treatments
Tags
Trial Sponsors
  • MD Anderson Cancer Center
NCT Identifier

NCT02861417

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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-Hodgkin's lymphoma; h) Hodgkin's Lymphoma; i) Multiple myeloma.
  2. Patients must have a haploidentical related donor or a fully matched related or unrelated donor.
  3. Ages >/= 12 and
  4. Performance score of >/= 70 by Karnofsky/Lansky or PS 0 to 1 (ECOG
  5. Left ventricular ejection fraction >/= 50%.
  6. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (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 by Cockcroft-Gault using adjusted body weight if actual body weight is 20% greater than ideal is permitted) should be >50 ml/min.
  8. Bilirubin
  9. Negative Beta human chorionic gonadotropin (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 able to sign informed consent.

Exclusion Criteria:

  1. HIV seropositivity.
  2. Uncontrolled infections.
  3. Patients with comorbidity score > 3.
  4. Prior allogeneic transplant
  5. Patients with active Hepatitis B and C.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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