18 and older, any sex, with Recurrent Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Toxicity, Defined as Adverse Events Classified as Possibly, Probably, or Definitely Related to Study Treatment, Graded According to the Grading Scale for Hematologic Adverse Events in CLL Studies or Ordinal Common Toxicity Criteria (Phase I)Secondary· Up to 2 years
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. Here, we report the number of patients that reported a grade 2 or higher as their worst incidence of toxicity.
Group
Value
95% CI
Dose Level 1 (Lenalidomide in Combination With AT-101)
1
Dose Level 1 (Lenalidomide in Combination With AT-101)
4
Dose Level 1 (Lenalidomide in Combination With AT-101)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Level 1 (Lenalidomide in Combination With AT-101)
Serious: 2/5 (40%)
Deaths: 0/5
Serious adverse events (3 terms)
Reaction
System
Dose Level 1 (Lenalidomide…
Fatigue
General disorders
—
Lung infection
Infections and infestations
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
Other adverse events (12 terms — click to expand)
Reaction
System
Dose Level 1 (Lenalidomide…
Anemia
Blood and lymphatic system disorders
—
Neutrophil count decreased
Investigations
—
Platelet count decreased
Investigations
—
Constipation
Gastrointestinal disorders
—
Fatigue
General disorders
—
Upper respiratory infection
Infections and infestations
—
Alanine aminotransferase increased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Blood bilirubin increased
Investigations
—
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with R-(-)-gossypol acetic acid and to see how well they work in treating patients with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, may stimulate the immune system to attack cancer cells. R-(-)-gossypol acetic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and causing the cells to die. Giving lenalidomide with R-(-)-gossypol acetic acid may be an effective treatment for relapsed or refractory B-CLL. - Funding Source - FDA OOPD
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 16 June 2020
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/NCT01003769.