Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies (NCT00710528) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies
United States192 participantsStarted 2008-06
Plain-language summary
The purpose of this study is to determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \> or = 18.
✓. Has relapsed or refractory disease as defined by the following:
✓. Disease status requirement:
✓. WHO performance status of ≤ 2.
✓. For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
✓. Is able to provide written informed consent.
Exclusion criteria
✕. Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to screening.
✕. For CLL or NHL patients, had treatment with a short course of corticosteroids for symptom relief within 1-week prior to screening.
✕. Had alemtuzumab therapy within 12-weeks prior to screening.
✕. For AML patients, had treatment with hydroxyurea within 1-week prior to screening.
✕. Is pregnant or nursing.
✕. Has significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug.
✕. Has had a transplant with current active graft-versus-host-disease.
What they're measuring
1
To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.