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| Stage | Trial details | Observations/results | Reference |
|
| Phase I | 31 patients with pegaspargase dose ranging from 500 to 8000 U m−2. | Mean half-life—357 h; dose unrelated hypersensitivity in small population of patients. | [67] |
| Patients with advanced solid tumors; pegaspargase dose 250–2000 U m−2 every 14 days. | L-aspargine level were found to be very low which was again a function of dose. 2000 U m−2 dose showed adverse effects such as fatigue, nausea/vomiting and weight loss. Hence dose escalation beyond 2000 U m−2 was not evaluated. | [76] |
| Low-dose (500 units m−2) in children with relapsed acute lymphoblastic leukemia. | L-asparaginase activity >100 U L−1 was demonstrated for atleast 1 week. Indicating in possibility reduction in dose. | [77] |
| Five patients with AIDS related lymphoma treated with 1500 U m−2 every 2 weeks. | Three patients showed complete response. | [78] |
|
| PEG-L-asparaginase as a single agent in patients (22) with recurrent and/or refractory multiple myeloma. | Maximal tolerated dose for single agent PEG-L-asparaginase in relapse/refractory multiple myeloma patients was found to be 1000 mg m−2 every 4 weeks. | [79] |
| Phase II | Patients earlier demonstrated sensitivity to L-asparaginase was treated with pegaspargase and other agents. | 36% patients demonstrated complete response while 15% partial response. | [80] |
| Newly diagnosed adults (14) with acute lymphoblastic leukemia (ALL) treated with 2000 U m−2 pegaspargase and multidrug regimen consisted of vincristine, prednisone, and danorubicin. | 93% patients revealed complete response. | [81] |
| Seven patients with refractory acute leukemias; dose 2000 U m−2 on days 1, 14, and 28 with other agents. | Five patients demonstrated complete response while one showed partial response. | [82] |
| An open-label, multicenter study involving 21 patients with recurrent lymphoblastic leukemia with pegaspargase, 2000 U m−2 single dose. After 14 days patients were treated with multidrug therapy regime consisting of vincristine, prednisone, and some patients with doxorubicin and intrathecal therapy. | On day 14, 17% of patients (from 18) achieved complete response and 1% partial response.
On day 35 (after the multidrug regime therapy), 67% patients demonstrated complete response and 11% showed partial response. The overall response rate was 78%. | [83] |
| Pediatric oncology group study: patients with acute lymphoblastic leukemia treated with 2500 U m−2 with multidrug regime either weekly or every two weeks. | Highly significant 93% complete response was observed in the patients receiving weekly therapy as compared to 82% in patients receiving every two weeks. | [84] |
|
| Phase III | Reinduction of relapsed acute lymphoblastic leukemia: 2500 U m−2 pegaspargase on day 1 and 15 or 10,000 U m−2 L-asparaginase three times a week for 12 doses, both with multidrug regime. | Despite difference in dose and dosing rate the complete response and partial response rates were almost similar (63 and 65% for pegaspargase and L-asparaginase, resp.). | [85] |
| Randomized trial involving Children with newly diagnosed acute lymphoblastic leukemia; 2500 U m−2 pegaspargase on day 1 or 6000 U m−2L-asparaginase three times a week for three weeks. | Pegaspargase achieved faster rate of remission. Complete response rate was almost similar (98% versus 100% for pegaspargase and L-asparaginase, resp.) despite significant difference in dose and dosing rates. | [86] |
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