At a glance
ClinicalIndex Comparison Record- ✓Age >1 and <21 years at study entry
- ✓ALL patients in clinical remission (BM morphology <5% blasts, CNS 1 status) or AML patients in M1 (<5% blasts) or M2 (<20% blasts) marrow status with CNS 1 status
- ✓ANC >750/µL
- ✓HLA-identical sibling, completely matched unrelated (10/10), or 1 allelic mis-matched unrelated donor
- ✕Active, progressive invasive infection; active uncontrolled systemic fungal, bacterial, viral, or other infection
- ✕Diagnosis of CML or MDS
- ✕CNS 2 or CNS 3 status
- ✕HIV positive
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Feasibility Study of Clofarabine and Low Dose Total Body Irradiation (TBI) as a Non-myeloablative Preparative Regimen for Stem Cell Transplantation (SCT) for Hematologic Malignancies
In Brief
A Phase 1 clinical trial evaluating Clofarabine, Total Body Irradiation, and 3 other interventions for Leukemia Lymphoblastic, Acute and 2 related conditions. Completed, enrolled 18 participants across 6 sites.
Detailed Summary
Stem cell transplant is an important therapeutic option for pediatric patients with relapsed or refractory leukemia. Although, full myeloablative transplants are widely used for patients with acute leukemia, myeloablative chemo-radiotherapy may not be feasible in some specific settings. These settings include 1) patients with pre-existing health issues and organ toxicities; 2) patients who have relapsed post-ablative transplant and need a second stem cell transplant; and 3) leukemia patients with advanced disease who have been heavily pre-treated. Clofarabine, a new purine nucleoside anti-metabolite, has the advantage of significant antileukemic activity in addition to its possible immuno-suppressive properties. In this study we plan to determine the maximum feasible dose (MFD) of Clofarabine in combination with total body irradiation that can achieve durable donor engraftment without causing excessive toxicity.
Study Details
Timeline
Interventions
Clofarabine will be given as an intravenous infusion over 2 hours on days -6 though -2. The dose of Clofarabine will be assigned at study entry (30, 40 or 52 mg/m2).
Low dose (2 Gy) TBI will be administered from a linear accelerator at ≤ 20 cGy/min on day "0" according to institutional guidelines.
Patients will be infused with 'unmanipulated' hematopoietic stem cells from a related or unrelated donor on day 0 of the treatment regimen according to institutional practice guidelines.
Cyclosporine is given IV based on body weight at: * Age ≤ 6 years old: 6 mg/kg IV QD. in divided doses (e.g. 2 mg/kg q8hrs). * Age \> 6 years old: 3 mg/kg IV QD in divided doses (1.5mg/kg q12hrs) Cyclosporine should be started on day -1 after completion of Clofarabine. Levels should be maintained between 300-400 ng/ml.
MMF will be at 15 mg/kg, based on adjusted body weight, q 8 hours (45 mg/kg/day; max.3g/day) PO, or IV if indicated, from the evening of day 0 (i.e. first dose 4-6 hours following stem cell infusion) to day +40 post-transplant. Oral doses will be rounded to the nearest 250 mg (capsules are 250 mg). MMF is also available in oral suspension form. MMF will be given until day +40 post transplant and then tapered by 10% per week to be discontinued by day +90.