NCT02861417Active, not recruitingPhase 2
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
Timed Sequential Busulfan and Post Transplant Cyclophosphamide for Allogeneic Transplantation
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant. Drugs used in chemotherapy, such as busulfan, fludarabine phosphate and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy such as busulfan and fludarabine phosphate before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (actual)
- First submitted
- 5 Aug 2016
- Start date
- 5 Aug 2016
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Acute lymphoblastic leukaemia, Myeloproliferative neoplasms, Hodgkin lymphoma, Chronic myeloid leukaemia, Myelodysplastic syndromes, Chronic lymphocytic leukaemia, Multiple myeloma, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT02861417
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 204
- From 5 Aug 2016 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic transplant
- Patients with prior coronary artery disease
- Patients who received inotuzumab and/or gemtuzumab in the past
Other illness
- Human immunodeficiency virus (HIV) seropositivity
- Uncontrolled infections
- Patients with active hepatitis B and C
Other
- Patients with comorbidity score \> 3; the principal investigator is the final arbiter of eligibility for comorbidity score \> 3
Who the study is looking for
- 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 lymphoproliferative disorder; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkin's lymphoma; h) Hodgkin's Lymphoma; i) Multiple myeloma
- Patients must have a haploidentical related donor or a fully matched related or unrelated donor
- Performance score of \>= 70 by Karnofsky/Lansky or performance score (PS) 0 to 1 (Eastern Cooperative Oncology Group \[ECOG\] =\< 1)
- Left ventricular ejection fraction \>= 50%
- Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the 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
- 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
- Bilirubin =\< 2 x the upper limit of normal (except with patients high indirect bilirubin due to Gilbert's syndrome, hypersplenism, or hemolysis)
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 200
- 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
- Patient or patient's legal representative able to sign informed consent
Age in the registry: 12 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.