Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

NCT00360672 | Completed Phase 2 Results

• 1 other identifier: 2006-0293
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if Revlimid can help to control the disease in patients with relapsed/refractory acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with abnormalities in chromosome number 5. The safety of this treatment will also be studied.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Keywords

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses)

  Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) \>1 \* 10\^9/L, platelet count ≥100 \* 10\^9/L, \< 5% of blast cells in bone marrow. CRp: as above except platelet count \<100 \* 10\^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.

  Following three 28-day cycles evaluated for response

Study Arms (1)

Revlimid

EXPERIMENTAL

Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).

Drug: Revlimid

Interventions

Revlimid DRUG

25 mg/day, orally for 21 days with 7 days rest (28 day cycle).

Also known as: Lenalidomide, CC-5013

Revlimid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age \>/= 18 years at the time of signing the informed consent form. (Revlimid has not been tested in younger patients)
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of relapsed/refractory AML (other than APL) or high-risk MDS (IPSS categories intermediate-2 and high) with chromosome 5 abnormality as a sole abnormality or with additional abnormalities. MDS patients with blast percentage of \>/= 10% will be considered high-risk.
• All non-hematological toxicity of previous cancer therapy should have resolved to \</= grade1 (except alopecia or other toxicities not involving major organs).
• Should not have received any prior treatment for AML or MDS within 2 weeks of starting Revlimid. Use of hydrea to control proliferative disease will be allowed prior to starting Revlimid and for 7 days during cycles 1 and 2 (Maximum daily dose of 7gm).
• Eastern Cooperative Oncology Group (ECOG) performance status of \</ =2 at study entry
• Laboratory test results within these ranges: • Serum creatinine \</= 1.5 mg/dL • Total bilirubin \</=1.5 mg/dL • aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \</=2 \* upper limit of normal (ULN) or \</=5 \* ULN if related to disease
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of prescribing Revlimid (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking Revlimid. FCBP must also agree to ongoing pregnancy testing.
• (continued from above) Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• Disease free of prior malignancies for \>/ = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Revlimid).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or experimental therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of Revlimid.
• Known positive for HIV or infectious hepatitis type B or C.
• Heart rate less than or equal to 50.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Gautam Borthakur, M.D./Associate Professor
• Organization: UT MD Anderson Cancer Center

eharriso@mdanderson.org

713-563-1586

Study Officials

• Gautam Borthakur, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 7, 2006
• Study Start: January 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 14, 2013
• Results First Posted: August 1, 2013

Record last verified: 2013-08

Locations

US (1)