Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic Malignancies

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Hematologic Malignancies, Acute Lymphocytic Leukemia, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Myelofibrosis, Myeloproliferative Syndrome

In brief

This phase I trial studies the side effects and best dose of targeted marrow irradiation when given with fludarabine phosphate and busulfan before donor progenitor cell transplant in treating patients with hematologic malignancies. Targeted marrow irradiation is a type of specialized radiation therapy that delivers a high dose of radiation directly to the cancer cells, which may kill more cancer cells and cause less damage to normal cells. Giving targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and busulfan, before a donor progenitor cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's progenitor cells. When the healthy progenitor cells from a donor are infused into the patient they may help the patient's bone marrow make progenitor cells, red blood cells, white blood cells, and platelets.

Key facts

Study ID: NCT02129582
Run by: Case Comprehensive Cancer Center
People needed: 14
Starts: 2014-11-05
Expected to finish: 2020-03-05
Last updated by the study team: 2021-05-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients ineligible to receive full myeloablative conditioning regimen for allogeneic hematopoietic progenitor cell transplant due to age or comorbidities
Patients must have histologically or cytologically diagnosis of hematologic malignancies with an indication for allogeneic hematopoietic progenitor cell transplantation, who are ineligible to receive a full ablative conditioning regimen as part of their transplantation, including:
Acute myeloid leukemia
Acute lymphocytic leukemia
Non Hodgkin lymphoma
Hodgkin lymphoma
Multiple myeloma
Myelodysplastic syndrome
Chronic lymphocytic leukemia
Chronic myeloid leukemia:
Myeloproliferative syndromes including myelofibrosis
Complete remission is not necessary for enrollment in this protocol
Patients must have an allogeneic hematopoietic progenitor cell donor (HPCT), either a matched sibling, mismatched (1 allele) sibling, or a matched unrelated donor (MUD) or a mismatched (1 allele) unrelated donor
Previous hematopoietic progenitor cell transplantation is allowed; a minimum of 6 months should have elapsed from prior autologous hematopoietic progenitor cell transplantation and a minimum of 6 months should have elapsed since prior allogeneic hematopoietic progenitor cell transplantation; prior transplantation with conditioning regimens using total body irradiation is not allowed
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy of > 12 weeks, in the opinion of and as documented by the investigator
Patients must have adequate hepatic, and renal function as defined below: there is no exclusion for the presence of cytopenias
Total bilirubin ≤ 1.5 times the institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 X institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 X institutional upper limit of normal
Creatinine clearance (calculated by the Cockroft-Gault formula) ≥ 60 ml/min
Pulmonary Function Tests (FEV1, FVC, DLCO) 40%.
Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) from the time of study entry, for the duration of study participation and for 3 months after completing treatment; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
Subjects must have the ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

Prior non-hematologic treatment toxicities must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of the following grade 2 toxicities: alopecia; dry skin; spleen disorders, hearing impairment; tinnitus; hypothyroidism; hyperthyroidism; endocrine disorders; blurred vision; cataracts; constipation; gastroesophageal reflux; fatigue; abnormal coagulation tests INR and/or aPTT; weight gain or weight loss; anorexia; glucose intolerance; hypoalbuminemia; hypokalemia; muscle weakness; dysgeusia; paresthesias; peripheral motor and/or sensory neuropathy; hot flashes; hypertension.
Patients must not have received other investigational agents within 14 days of initiation of the conditioning regimen
Patients with untreated brain metastases should be excluded from this clinical trial
History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine and or busulfan or other agents used in this study
Prior allogeneic hematopoietic progenitor cell transplantation
Prior autologous hematopoietic progenitor cell transplantation if the conditioning regimen included total body irradiation
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; this exclusion criterion does not include the underlying disease for which the patient is undergoing hematopoietic progenitor cell transplantation
Pregnant or breastfeeding women are excluded from this study; breastfeeding should be discontinued
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Patients with a history of therapy with radiation therapy are excluded
Due to technical limitations of TMI, patients must be no taller than 1.9 m (6 feet 4 inches), and no wider from elbow to elbow in the supine position than 60 cm.

Where it is running

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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