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

Launched by UNIVERSITY OF CHICAGO · Jan 6, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients whose blood cancers, like acute myeloid leukemia or myelodysplastic syndrome, have returned after initial treatment. The study focuses on using a special type of radiation called intensity modulated total marrow irradiation (IMTMI), along with two chemotherapy drugs, fludarabine phosphate and melphalan, before a second stem cell transplant from a donor. The goal is to find out the best dose of these treatments and to see how they affect patients, with the hope that this combination will help reduce side effects and improve outcomes by preparing the bone marrow for the new healthy stem cells.

To be eligible for this trial, participants need to be between the ages of 18 and 75 and have specific types of blood cancers that have relapsed. They should also be in reasonably good health, with a performance status of 70 or above, meaning they can carry out daily activities with some limitations. Participants will undergo the new treatment regimen and then receive a stem cell transplant, which is expected to help their body rebuild healthy blood cells. It's important to note that patients will need to have a suitable donor for the stem cell transplant, which could be a matched relative or an unrelated donor from a registry. This trial is currently recruiting participants, and individuals interested should discuss it further with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Karnofsky performance status of 70 or above
• • Life expectancy is not severely limited by concomitant illness
• • 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
• • 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)
• • Serum bilirubin =\< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI
• • 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
• • No evidence of chronic active hepatitis or cirrhosis
• • Human immunodeficiency virus (HIV)-negative
• • Patient is not pregnant
• • Patient or guardian able to sign informed consent
• • 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
• * 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):
• • Age of donor (18-24 \> 25-34 \> 35-44 \> 45+)
• • Sex of donor (male \> female, nulliparous female \> parous, multiparous female)
• • Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- \> CMV+