Eflapegrastim for Pediatric Solid Tumors and Lymphomas

A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

Recruiting Phase 2 Interventional Study
Solid Tumors Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
1 Month – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Spectrum Pharmaceuticals, Inc · Industry
Who this trial is looking for

This trial is looking for children and young adults with newly diagnosed or relapsed solid tumors or lymphomas. Participants will receive the drug eflapegrastim after undergoing chemotherapy that affects the bone marrow.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a confirmed diagnosis of a solid tumor or lymphoma.
  • I will receive chemotherapy that causes low white blood cell counts.
  • I have good blood, kidney, and liver function.
  • I have had a heart test that shows my heart is functioning well.
  • I have been checked for any brain involvement if needed.
  • I have a performance level that shows I am able to do daily activities.

You may not be able to join if

  • I have an uncontrolled infection or a serious illness that prevents treatment.
  • I have received certain drugs like filgrastim or pegfilgrastim recently.
  • I need radiation therapy at the same time as the first cycle of treatment.
  • I have had a bone marrow transplant or my cancer involves my bone marrow.
  • I have had spinal radiation therapy recently.
  • I have used any experimental drugs or treatments in the past month.
  • I am allergic to or have had bad reactions to G-CSF products.
  • I have active disease in my brain.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement. 2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as …
Contacts

Howard Franklin, MD

224.419.7106

Hfranklin@assertiotx.com

CONTACT