CompletedPhase 1

Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Leukemia

United States31 participantsStarted 2015-06-25

Plain-language summary

This phase I trial studies the side effects and best dose of total bone marrow and lymphoid irradiation when given together with chemotherapy before donor stem cell transplant in treating patients with myelodysplastic syndrome or acute leukemia. Total marrow and lymphoid irradiation is a type of radiation therapy that targets bone marrow and blood, where the cancer is, instead of applying radiation to the whole body. Stem cell transplants use high doses of chemotherapy and radiation therapy, such as total marrow and lymphoid irradiation, to kill cancer cells, but these treatments kill normal cells as well. After chemotherapy, healthy cells from a donor are given to the patient to help the patient grow new blood cells.

Who can participate

Age range12 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eligible patients will have a histopathologically confirmed diagnosis of hematologic malignancy in one of the following categories: * Acute myelogenous leukemia * In first complete remission (CR1) with poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for acute myeloid leukemia (AML): monosomal karyotype, -5, 5q-,-7,7q-, inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (\>= 3 unrelated abnormalities \[abn\]) and normal cytogenetics with fms-related tyrosine kinase 3 (FLT3)-internal tandem duplications (ITD) mutation * In pediatrics, all of the above and 11q23-non t(9;11) * In second complete remission (CR2) or third complete remission (CR3) * With chemosensitive primary refractory disease * Acute lymphocytic leukemia * In CR1 with poor risk cytogenetics: * For adults according to NCCN guidelines for acute lymphoblastic leukemia (ALL): hypoploidy (\< 44 chromosomes); t(v;11q23): mixed lineage leukemia (MLL) rearranged; t(9;22) (q34;q11.2); complex cytogenetics (5 or more chromosomal abnormalities); high white blood cell (WBC) at diagnosis (\>= 30,000 for B lineage or \>= 50,000 for T lineage) * For pediatrics t(9;22), intrachromosomal amplification of chromosome 21 (iAMP21)loss of 13q, and abnormal 17p * In CR2 or CR3 * With chemosensitive primary refractory disease * Myelodysplastic syndrome in high-intermediate (int-2) and high risk categories * Karnofsky…

What they're measuring

Incidence of dose-limiting toxicity (DLT) scored on both the Bearman Scale and National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Timeframe: Up to 100 days

Maximum tolerated dose of TMLI when given in combination with fludarabine phosphate and cyclophosphamide, defined as the highest dose where 6 patients have been treated and at most one patient experiences DLT

Timeframe: Up to day -3

Trial details

NCT IDNCT02446964

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-20

View on ClinicalTrials.gov More Adult Acute Lymphoblastic Leukemia in Complete Remission trials