NCT01629082

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

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing Clofarabine in Myeldysplastic Syndrome (MDS) in 4 participants. Completed in 27 June 2018.

Timeline

6 June 2012

Primary endpoint
27 October 2015

27 June 2018

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	6 June 2012
Primary completion	27 October 2015
Estimated completion	27 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Clofarabine (CLOFARABINE) — full drug profile →
• Lenalidomide — full drug profile →

Conditions studied

• Myeldysplastic Syndrome (MDS) — all drugs for Myeldysplastic Syndrome (MDS) →
• Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
• Bone Marrow Diseases — all drugs for Bone Marrow Diseases →
• Neutropenia — all drugs for Neutropenia →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 99, any sex, with Myeldysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Approaches in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.
   Ramos NR, Mo CC, Karp JE, Hourigan CS. · · 2015 · cited 91× · PMID 25932335 · DOI 10.3390/jcm4040665
2. Trial Watch: Lenalidomide-based immunochemotherapy.
   Semeraro M, Vacchelli E, Eggermont A, Galon J, et al · · 2013 · cited 46× · PMID 24482747 · DOI 10.4161/onci.26494
3. Cellular immune profiling after sequential clofarabine and lenalidomide for high risk myelodysplastic syndromes and acute myeloid leukemia.
   Jain P, Klotz J, Dunavin N, Lu K, et al · · 2017 · cited 5× · PMID 28462085 · DOI 10.1016/j.lrr.2017.04.003