Study Summary
This trial is testing a new cancer treatment regimen that includes the drug lenalidomide. Lenalidomide is already approved for other types of cancer, but its use in this particular cancer is experimental. The goal of the trial is to find the best dose of lenalidomide to give with standard chemotherapy drugs, and to learn about any side effects of this combination treatment.
Eligible Conditions
- Adult T-Cell Leukemia/Lymphoma
- Chronic Adult T-Cell Leukemia/Lymphoma
- Acute Adult T-Cell Leukemia/Lymphoma
- Human T-cell Leukemia Virus-1 Infection
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Up to 2 years after completion of study treatment
Year 2
Duration of response
Year 2
HTLV-1 clonality
Human T-cell leukemia virus type 1 (HTLV-1) proviral deoxyribonucleic acid and ribonucleic acid loads
Overall response rate
Overall survival
Progression-free survival
T-cell receptor pathway gene mutational spectrum
Up to the end of induction therapy
Incidence of toxicities
Maximum tolerated dose (MTD)
Trial Safety
Safety Progress
Side Effects for
Phase 1 and Phase II: Event Free Survival and Overall Survival
44%Neutrophil count decreased
8%Infusion related reaction
8%Weakness
6%Fever
6%Fatigue
6%Platelet count decreased
6%Investigations - Other, specify
3%Infections and infestations - Other, specify
3%Hypokalemia
3%Left ventricular systolic dysfunction
3%Atrial fibrillation
3%Respiratory Failure
3%Myocardial infarction
3%sepsis
3%Chest pain
3%Pleural effusion
3%Atrial flutter
3%Cardiac arrest
3%Renal and urinary disorders - Other, specify
3%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
3%Respiatory, thoracic and mediastinal disorders - Other, specify
3%confusion
3%Respiratory, thoracic and medicastinal disorders - Other, specify
3%Abdominal Pain
3%Nausea
3%Injury, poisoning and procedural complications - Other, specify
3%Acidosis
3%Cough
3%Encephalopathy
3%Aortic valve disease
Trial Design
1 Treatment Group
Treatment (lenalidomide, EPOCH)
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Lenalidomide · No Placebo Group · Phase 1
Treatment (lenalidomide, EPOCH)Experimental Group · 6 Interventions: Cyclophosphamide, Etoposide, Doxorubicin Hydrochloride, Lenalidomide, Vincristine Sulfate, Prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Beta-D-Glucose
Not yet FDA approved
Doxorubicin
FDA approved
Lenalidomide
FDA approved
Sulfate ion
Not yet FDA approved
Methylprednisolone
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after completion of study treatment
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,087 Previous Clinical Trials
41,141,676 Total Patients Enrolled
Lee RatnerPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
3 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patient has an absolute neutrophil count (ANC) of 1,000/mm^3 or more.
You have previously received azidothymidine (AZT), interferon (IFN), bexarotene, or mogamulizumab.
For patients who receive a cycle of EPOCH prior to enrollment on the protocol, cycle 2 (the first cycle on protocol) dose of EPOCH is altered according to toxicities in cycle 1.
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Conditions
Cancer Related
Treatments