New transplant recipe may tame Graft-Versus-Host disease in blood cancer patients
NCT ID NCT02861417
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests a specific timing of chemotherapy drugs (busulfan and fludarabine) before a donor stem cell transplant, followed by cyclophosphamide after the transplant, to treat high-risk blood cancers like leukemia and lymphoma. The goal is to reduce the chance of the transplant attacking the patient's body (graft-versus-host disease) while still killing cancer cells. About 204 participants will be enrolled to see if this approach lowers the risk of death from non-relapse causes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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204 people
The number who actually took part.
- Started
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Aug 2016
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Exclusion Criteria: * Human immunodeficiency virus (HIV) seropositivity * Uncontrolled infections * Patients with comorbidity score \> 3; the principal investigator is the final arbiter of eligibility for comorbidity score \> 3 * Prior allogeneic transplant * Patients with active hepatitis B and C * Patients with prior coronary artery disease * Patients who received inotuzumab and/or gemtuzumab in the past
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Four-Drug combo aims to push High-Risk myeloma into deep remission
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?