Total Marrow Irradiation for Refractory Acute Leukemia

Completed · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Multiple Myeloma

In brief

RATIONALE: Giving chemotherapy and total marrow irradiation before a donor umbilical cord blood or hematopoietic stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of total marrow irradiation when given together with combination chemotherapy and umbilical cord blood hematopoietic stem cell transplant in treating patients with acute leukemia, acute myeloid leukemia or multiple myeloma that did not respond to previous therapy.

Key facts

Study ID

NCT00686556

Run by

Masonic Cancer Center, University of Minnesota

People needed

12

Starts

2012-08-01

Expected to finish

2016-12-01

Last updated by the study team

2017-12-05

Who can join

Age: any, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute lymphoblastic leukemia
• ≥ Complete remission 2 (CR2) (adults ≥ 18 years and ≤ 55 years)
• CR2 in pediatrics (defined as <18 years) and <12 months duration of first remission
• ≥ CR3 or not in remission (pediatric patients <18 years)
• T cell leukemia ≥ CR2
• Evidence of pre-transplant minimal residual disease (MRD) by flow cytometry, FISH or cytogenetics
• Myelodysplastic syndrome
• ≤ 55 years of age and ≥ 10% blasts, not responsive to hypomethylating agents and/or conventional therapy
• Acute myeloid leukemia
• Not in remission (pediatric patients <18 years)
• Not in remission (10-30% blasts in the bone marrow for adult patients ≥18 years and ≤ 55 years)
• Evidence of pre-transplant minimal residual disease (MRD) by flow cytometry, FISH or cytogenetics
• Multiple myeloma
• No prior autologous transplant and fitting into one of the following disease categories:
• Early disease stage (CR1/PR1) with high-risk molecular features
• Early disease stage (CR1/PR1) with high-risk clinical features
• Late disease stage (CR2/PR2+) with high-risk clinical features
• Other high risk hematologic malignancies - to be approved by 2 or more hematology/oncology and BMT physicians
• Patients with prior CNS involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
• Have acceptable organ function within 14 days of study registration defined as:
• Renal: glomerular filtration rate > 60ml/min/1.73m2
• Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP) < 5 x upper limit of normal (ULN)
• Pulmonary function: Carbon Monoxide Diffusing Capacity corrected (DLCOcorr) > 50% of normal, (oxygen saturation [>92%] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
• Cardiac: left ventricular ejection fraction ≥ 45% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
• Karnofsky performance status (PS) >80% for ages 16 years and older or Lansky Play Score >50 for < 16 years

You may not qualify if…

• Active uncontrolled infection at time of enrollment or documented fungal infection within 3 months.
• Evidence of Human immunodeficiency virus (HIV) infection
• Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
• Prior myeloablative transplant within the last 6 months
• Prior total body irradiation (TBI) making total marrow irradiation (TMI) not feasible

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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