Using targeted radiation and chemotherapy for patients with relapsed blood cancers undergoing a second stem cell transplant
A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
This study is testing a new combination of targeted radiation and chemotherapy to see if it can safely help patients with relapsed blood cancers prepare for a second stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | radiation, fludarabine |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT02333162 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and optimal dosage of intensity modulated total marrow irradiation (IMTMI) combined with fludarabine phosphate and melphalan for patients with relapsed hematologic cancers undergoing a second donor stem cell transplant. The study aims to assess the maximum tolerated dose of IMTMI and evaluate its effects on transplant-related mortality, engraftment times, overall survival, and event-free survival. By using IMTMI, the trial seeks to minimize toxicity while effectively preparing patients for the transplant process.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed acute myeloid leukemia, high-risk myelodysplastic syndrome, or other hematologic malignancies who are eligible for a second allogeneic stem cell transplant.
Not a fit: Patients with severe comorbidities or those whose life expectancy is significantly limited by other illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve outcomes for patients with relapsed hematologic cancers by enhancing the effectiveness of stem cell transplants while reducing side effects.
How similar studies have performed: While this approach is innovative, similar studies using targeted radiation therapies have shown promise in improving transplant outcomes.
Eligibility criteria
Show full inclusion / exclusion 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+
Where this trial is running
Chicago, Illinois
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Hongtao Liu — University of Chicago Comprehensive Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.