RECRUITING

Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant

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Conditions

Previously Treated Myelodysplastic SyndromeRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Hematologic Malignancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of radiation therapy to the bone marrow that may be less toxic and may also reduce the chances of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and 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.

Official Title

A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

Quick Facts

Study Start:2014-12-05
Study Completion:2028-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02333162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with the following diseases: acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) undergoing second allogeneic (allo)-stem cell transplant (SCT) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL), will be at the discretion of the investigators
  2. * Karnofsky performance status of 70 or above
  3. * Life expectancy is not severely limited by concomitant illness
  4. * Adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (LVEF) =\< 40% or diffusion capacity of carbon monoxide (DLCO) =\< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
  5. * Serum creatinine =\<1.5 mg/dL or creatinine clearance \> 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (PI)
  6. * Serum bilirubin =\< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI
  7. * Serum glutamic oxaloacetic transaminase (SGPT) \< 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the PI
  8. * No evidence of chronic active hepatitis or cirrhosis
  9. * Human immunodeficiency virus (HIV)-negative
  10. * Patient is not pregnant
  11. * Patient or guardian able to sign informed consent
  12. * DONOR: Since these patients already had first allo-SCT; in the majority time, the same matched donor has been used for second allo-SCT; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT; the donor could be matched related donors or matched unrelated donors from registry
  13. * DONOR: If more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (SOP):
  14. * Age of donor (18-24 \> 25-34 \> 35-44 \> 45+)
  15. * Sex of donor (male \> female, nulliparous female \> parous, multiparous female)
  16. * Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- \> CMV+
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Hongtao Liu
PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center

Study Locations (Sites)

University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Hongtao Liu, PRINCIPAL_INVESTIGATOR, University of Chicago Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-12-05
Study Completion Date2028-12-01

Study Record Updates

Study Start Date2014-12-05
Study Completion Date2028-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Hematologic Malignancy