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Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

NCT01629082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

* Several types of blood cancer are associated with poor outcomes including high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for standard treatments. New types of treatment are needed for these cancers.
* Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the body. The second can alter blood supply to abnormal cells or affect how the immune system attacks these cells. These drugs have been previously tested as treatments for MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and AML. Researchers want to see if these drugs are safe and effective for these types of cancer.

Objectives:

\- To test the safety and effectiveness of clofarabine and lenalidomide for people with high-risk MDS, CMML, and AML.

Eligibility:

* Individuals at least 18 years of age who have high-risk MDS, CMML, and AML.
* Participants must not be candidates for standard treatments.

Design:

* Participants will be screened with a physical exam and medical history. Blood and bone marrow samples will be collected.
* Participants will have 5 days of treatment with clofarabine. It will be given through a vein during an inpatient hospital stay. If there are no serious side effects after the infusion, participants will continue treatment as outpatients.
* After 28 days, participants will have a bone marrow biopsy to check their response to treatment.
* After the biopsy, participants will start lenalidomide treatment. Half of the participants will take the drug for 28 days (one treatment cycle). The other half will take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor treatment.
* If there are no serious side effects and the disease does not become worse, participants may keep taking lenalidomide at lower doses for up to 12 more cycles.

Conditions

  • Myeldysplastic Syndrome (MDS)
  • Chronic Myelomonocytic Leukemia
  • Bone Marrow Diseases
  • Neutropenia
  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Clofarabine

DRUG

Lenalidomide

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Sawa Ito, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-06
Primary Completion
2015-10-27
Completion
2018-06-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629082 on ClinicalTrials.gov