CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Recruiting Phase 1 Interventional Study
Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

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

At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
7 (estimated)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for

This trial is looking for people who have recently been diagnosed with a specific type of leukemia. Participants will take a study drug called calaspargase pegol along with other chemotherapy treatments and will be monitored for safety and side effects.

Are You a Good Fit for This Trial?
Rules you out Down SyndromeActive infection requiring systemic therapySevere heart failureUncontrolled diabetes

You may be able to join if

  • I have been diagnosed with Philadelphia negative B- or T-cell acute lymphoblastic leukemia.
  • I have completed treatment and fully recovered from arm 1A of the Hyper-CVAD regimen.
  • I can provide written consent to participate in the trial.
  • I can follow the study visit schedule and requirements.
  • My Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
  • My heart function is normal with a cardiac ejection fraction of 50% or higher.
  • My serum bilirubin and creatinine levels are within normal limits.
  • I will use effective contraception if I am a female of childbearing potential.

You may not be able to join if

  • I have been treated with any induction therapy other than Hyper-CVAD 1A.
  • I have L3 type Burkitt's lymphoma.
  • I have active leukemia in my central nervous system.
  • I have had major surgery or radiation therapy in the last four weeks.
  • I have an active infection that needs treatment, including HIV or Hepatitis.
  • I have a serious medical condition that could affect my trial participation.
  • I have had recurrent thrombosis in the last three months.
  • I am pregnant, breastfeeding, or planning to have a child during the trial.

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.

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About This Trial

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia, with \>10% peripheral blood or bone marrow lymphoblasts at diagnosis. * Treatment and full recovery from arm 1A of the Hyper-CVAD regimen. * Be willing and able to provide written informe…
Contacts

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