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NCT01910428

A Phase I Study of L-asparaginase Encapsulated in Red Blood Cells (Eryaspase) in Combination With the CALGB Regimen During Induction and Consolidation Phases in the Treatment of Adult Patients With Acute Lymphoblastic Leukemia and Lymphoma

Terminated Phase 1 Last updated 2 July 2018
What this trial tests

Phase 1 trial testing L-asparaginase encapsulated in RBC in Acute Lymphoblastic Leukemia in 14 participants. Terminated before completion.

Timeline
1 October 2013
Primary endpoint
25 January 2018
1 March 2018

Quick facts

Lead sponsorERYtech Pharma
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date1 October 2013
Primary completion25 January 2018
Estimated completion1 March 2018
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

ERYtech Pharma — full company profile →

Who can join

18 and older, any sex, with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Asparaginase (Asp) is used during the induction phase of ALL treatment for children and young adults. Its efficacy is counterbalanced by its toxicity, mainly in patients 40 years or older. The efficacy rate in older adult population is lower than for children or young adults. A recent review on outcomes in older adults with ALL pointed out that there were significantly more drug reductions, omissions or delays in the older group as compared to younger adults and that asparaginase was the drug most commonly omitted. The investigational product ERYASPASE is a dispersion for infusion of homologous red blood cells (RBC) encapsulating E. coli L-asparaginase. A previous European phase I/II clinical study in children and adults (\<55 yo) at first relapse of ALL was conducted to determine the optimal dose of homologous RBC encapsulating native E. coli Asp (GRASPA®) in 24 patients with relapsed ALL. The activity and safety profiles of 3 doses of GRASPA® (50, 100 and 150 IU/kg) in combination with standard chemotherapy were compared to free native Asp. The global safety profile is also improved, reducing hypersensitivity, liver toxicity and coagulation disorders. Study showed that a single dose of GRASPA® 150 IU/kg induced a depletion in plasmatic asparagine for 18.6 days, i.e. similar to that obtained with 8 injections of 10,000 IU/m² of free native Asp. A reduction in the incidence and severity of the allergic reactions and coagulation disorders were observed with GRASPA® (Domenech 2011). A French phase II study designed to determine the maximum tolerated dose of GRASPA® in combination with a polychemotherapy regimen in ALL patients older than 55 yo at first diagnosis has been performed, and showed that both 100 and 150 IU/kg doses fulfilled the predefined criteria for efficacy and tolerability but the better profile of 100 IU/kg dose was considered the optimal dose in this setting. A phase II/III trial in adult and children patients with relapsed ALL is currently ongoing. Based on these results, the combination of ERYASPASE with the CALGB chemotherapy regimen appears to be an attractive combination for the treatment of adults patients with ALL/LBL.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Red blood cells: Supercarriers for drugs, biologicals, and nanoparticles and inspiration for advanced delivery systems.
    Villa CH, Anselmo AC, Mitragotri S, Muzykantov V. · · 2016 · cited 259× · PMID 26941164 · DOI 10.1016/j.addr.2016.02.007
  2. Theoretical basis, state and challenges of living cell-based drug delivery systems.
    Liu W, Cheng G, Cui H, Tian Z, et al · · 2024 · cited 11× · PMID 39267776 · DOI 10.7150/thno.99257
  3. The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia.
    Rose K, Walson PD. · · 2015 · cited 9× · PMID 26604845 · DOI 10.2147/rmhp.s63029

Verify or expand the search:

Other recruiting trials for Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01910428.

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