Last reviewed · How we verify
Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission
Phase 2 trial testing Laboratory Biomarker Analysis in Alkylating Agent-Related Acute Myeloid Leukemia in 29 participants. Completed in 30 November 2021.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 13 November 2014 |
| Primary completion | 30 November 2021 |
| Estimated completion | 30 November 2021 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Alkylating Agent-Related Acute Myeloid Leukemia or Secondary Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide) | 21.5 | 0.7 – 54.3 |
Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide) | NA | 1.3 – 54 |
Time from date of treatment start until the date of first objective documentation of disease-relapse, death or discontinuation due to adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide) | 12 | 0.5 – 54.3 |
Complete Response is defined as disappearance of all clinical and/or radiologic evidence of disease, including extramedullary leukemia. Neutrophil count \>/= 1.0 x 10\^9/L and platelet count\>/= 100 x 10\^9, and bone marrow differential showing \</=5%blasts. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not ava
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide) | NA | 0.7 – 54.3 |
Time frame: Up to 7 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Lenalidomide) |
|---|---|---|
| Cellulitis Hand | Infections and infestations | — |
| elevated transaminases | Metabolism and nutrition disorders | — |
| Chest Pain | General disorders | — |
| Cellulitis Foot | Infections and infestations | — |
| Bronchopneumonia | Infections and infestations | — |
| Dysarthria | Nervous system disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Reaction | System | Treatment (Lenalidomide) |
|---|---|---|
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Heartburn/dyspepsia | Gastrointestinal disorders | — |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | — |
| Platelets Thrombocytopenia | Blood and lymphatic system disorders | — |
| Pruritus/itching | Skin and subcutaneous tissue disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | — |
| Dry eye syndrome | Eye disorders | — |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | — |
| Headache | General disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | — |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | — |
| Itchy Scalp | Skin and subcutaneous tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Edema: limb | Blood and lymphatic system disorders | — |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10^ | Infections and infestations | — |
| Foot Cramps | Musculoskeletal and connective tissue disorders | — |
| Myalgia Back and Neck | Musculoskeletal and connective tissue disorders | — |
| Myositis (inflammation/damage of muscle) | Musculoskeletal and connective tissue disorders | — |
| Neuropathy: motor | Nervous system disorders | — |
| back pain | General disorders | — |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | — |
| Vision-photophobia | Eye disorders | — |
Most-reported serious reactions: Cellulitis Hand, elevated transaminases, Chest Pain, Cellulitis Foot, Bronchopneumonia, Dysarthria, Atrial Fibrillation, Pleural Effusion.
Data from ClinicalTrials.gov NCT02126553 adverse events section.
This phase II trial studies how well lenalidomide works in treating patients with acute myeloid leukemia that have had a decrease in or disappearance of signs and symptoms of cancer, although cancer still may be in the body and may be likely to come back or spread. Biological therapies, such as lenalidomide, use substances made from living organisms that may kill cancer cells by blocking blood flow to the cancer and by stimulating white blood cells to kill the cancer cells.
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT02126553.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing