Myelodysplastic SyndromePhase 1/2NCT00831766
Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)
A Phase 1/2 study testing Idarubicin, Cytarabine and Lenalidomide (Revlimid®) in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to: Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine See how long people respond to this combination therapy See how long people live after being… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- What is being tested?
- Idarubicin, Cytarabine and Lenalidomide (Revlimid®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jun 2009to 16 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Disease-specific criteria (Phase I):
- Previously untreated Acute Myeloid Leukemia (AML), associated with monosomy 5 or segmental deletion involving 5q31, either alone or with additional cytogenetic abnormalities
- Previously untreated AML (age ≥ 60 years)
- Myelodysplastic Syndrome, Refractory Anemia with Excess Blasts-2 (MDS,RAEB-2, 10-19% blasts in the bone marrow) associated with monosomy 5 or segmental deletion involving 5q31, either alone or with additional cytogenetic abnormalities
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- For MDS, patients must have had progression with or failed response to front-line therapy with a nucleoside analogue (azacitidine, decitabine).
- Disease Specific Criteria (Phase II)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Laboratory test results within these ranges:
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL (Gilbert's syndrome excluded)
- Aspartic transaminase (AST) and Alanine transaminase (ALT) ≤ 2 x upper limit of normal (ULN)
- 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
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide. For FCBP who have a medical need to proceed with therapy immediately, the pregnancy test that would normally be done 10-14 days prior to initiation of lenalidomide may be done as late as 7 days prior to initiation of lenalidomide. Both this test and the pregnancy testing done within 24 hours prior to initiation of lenalidomide must be negative. FCBP 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 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex* condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. *For patients who have latex allergies or whose partner(s) have latex allergies, alternatives will be discussed.
- Must be able to swallow capsules and no evidence of gastrointestinal (GI) tract abnormality that would alter absorption of oral medications
- Understand and voluntarily sign an informed consent form
- Life expectancy >3 months
- All study patients must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by RevAssist) 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 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Unwilling or unable to participate with Food and Drug Administration (FDA) mandated birth control and pregnancy guidelines
- Any condition, including the presence of laboratory abnormalities, which places the patient 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 therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
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- The development of erythema nodosum, if characterized by a desquamating rash, while taking thalidomide or similar drugs
- Any prior use of lenalidomide
- AML with cytogenetics including t(15;17), t(8;21), or inv(16)
- White blood count (WBC) count ≥ 50,000 on hydroxyurea therapy
- Previous history of induction chemotherapy for AML or allogeneic stem cell transplant
- Predicted inability to tolerate standard induction chemotherapy with idarubicin and cytarabine
- History of spontaneous thromboembolic event requiring use of anticoagulation with warfarin (coumadin) or low molecular-weight heparin within 3 years
- Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1/2 Study of Sequential Idarubicin + Cytarabine, Followed by Lenalidomide, in Patients With Myelodysplastic Syndrome (RAEB-2) or With Previously Untreated Acute Myeloid Leukemia
The purpose of this study is to:
- Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine
- See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine
- See how long people respond to this combination therapy
- See how long people live after being treated with this combination of drugs
Read the detailed description
All three drugs are FDA approved to treat patients in the United States of America. Idarubicin and Cytarabine combination therapy is a standard treatment for patients with acute myeloid leukemia (AML). Lenalidomide is FDA approved to retreat patients with Multiple Myeloma or Myelodysplastic syndrome with a specific change in their DNA. Loss of a specific part of DNA is also seen in some patients with AML.
This is a phase 1/2, dose-escalation trial of Lenalidomide given in combination with idarubicin + cytarabine. During phase 1, we will enroll patients with AML involving del 5q31; 2) patients with MDS RAEB-2 associated with monosomy 5 or segmental deletion involving 5q31, either alone or with additional cytogenetic abnormalities, and 3) older patients with any type of karyotypic profile in whom an effective and reliable standard of care remains to be developed. All 3 groups of patients define a population of patients with very poor prognoses. Dose escalation of lenalidomide will use a standard 3x3 design. Dose escalation of Lenalidomide only will take place, while the doses of idarubicin and cytarabine will be constant. This trial will have an induction component, consolidation component, and maintenance component. Overall safety and MTD will be determined from the induction phase only.
During phase 2, we will enroll only patients with AML age ≥ 60 years. During phase 2, the efficacy of this combination of Lenalidomide + idarubicin + cytarabine, at the maximum tolerated dose (MTD) for Lenalidomide (determined during phase 1), will be tested.
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Being tested
- Idarubicin, Cytarabine, Lenalidomide (Revlimid®)
- Keywords
- Hematopoietic, Myeloid and Monocytic Leukemia, AML
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdarubicinDrug
Also called Antineoplastic Agent
Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
CytarabineDrug
Also called Antineoplastic Agent
Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
Lenalidomide (Revlimid®)Drug
Also called Revlimid®
Lenalidomide as outlined in Phase I and Phase II Treatment Arms.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.
Idarubicin: 12 mg/m^2.
Cytarabine: 200 mg/m^2.
Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d. Receives: Drug: Idarubicin; Drug: Cytarabine; Drug: Lenalidomide (Revlimid®) |
| Phase II: Treatment at MTD | Experimental | Idarubicin: 12 mg/m^2.
Cytarabine: 200 mg/m^2.
Lenalidomide: Maximum Tolerated Dose (MTD). Receives: Drug: Idarubicin; Drug: Cytarabine; Drug: Lenalidomide (Revlimid®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Recommended Phase II Dose
For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.
Measured: 18 months
Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)
Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).
Measured: 24 months
Secondary outcomes (3)
Rate of Lenalidomide Related Toxicity During Maintenance Therapy
Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3. Adverse Events: Possibly Related; Probably Related, or Definitely Related to study treatment. Events are categorized as Grade 1 or 2, or as Grade 3 or 4.
Measured: 24 months
Median Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.
Measured: 24 months
Median Overall Survival (OS)
Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study start25 Jun 2009
- Primary completion17 Feb 2015
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Jeffrey Lancet, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831766
- Sponsor's protocol ID
- MCC-15625
- Other IDs
- RV-AML/MDS-PI-0269
- Status last verified
- Dec 2020
- First submitted
- 28 Jan 2009
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Sequential Idarubicin + Cytarabine, Followed by Lenalidomide, in Patients With Myelodysplastic Syndrome (RAEB-2) or With Previously Untreated Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00831766
- Acronym / sponsor ID
- MCC-15625
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Keywords
- Hematopoietic, Myeloid and Monocytic Leukemia, AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 25 Jun 2009 (actual)
- Primary completion
- 17 Feb 2015 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine
- See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine
- See how long people respond to this combination therapy
- See how long people live after being treated with this combination of drugs
Detailed description
All three drugs are FDA approved to treat patients in the United States of America. Idarubicin and Cytarabine combination therapy is a standard treatment for patients with acute myeloid leukemia (AML). Lenalidomide is FDA approved to retreat patients with Multiple Myeloma or Myelodysplastic syndrome with a specific change in their DNA. Loss of a specific part of DNA is also seen in some patients with AML.
This is a phase 1/2, dose-escalation trial of Lenalidomide given in combination with idarubicin + cytarabine. During phase 1, we will enroll patients with AML involving del 5q31; 2) patients with MDS RAEB-2 associated with monosomy 5 or segmental deletion involving 5q31, either alone or with additional cytogenetic abnormalities, and 3) older patients with any type of karyotypic profile in whom an effective and reliable standard of care remains to be developed. All 3 groups of patients define a population of patients with very poor prognoses. Dose escalation of lenalidomide will use a standard 3x3 design. Dose escalation of Lenalidomide only will take place, while the doses of idarubicin and cytarabine will be constant. This trial will have an induction component, consolidation component, and maintenance component. Overall safety and MTD will be determined from the induction phase only.
During phase 2, we will enroll only patients with AML age ≥ 60 years. During phase 2, the efficacy of this combination of Lenalidomide + idarubicin + cytarabine, at the maximum tolerated dose (MTD) for Lenalidomide (determined during phase 1), will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Drug: Idarubicin, Drug: Cytarabine, Drug: Lenalidomide (Revlimid®)Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed. Idarubicin: 12 mg/m^2. Cytarabine: 200 mg/m^2. Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d. |
| Phase II: Treatment at MTD | Experimental | Drug: Idarubicin, Drug: Cytarabine, Drug: Lenalidomide (Revlimid®)Idarubicin: 12 mg/m^2. Cytarabine: 200 mg/m^2. Lenalidomide: Maximum Tolerated Dose (MTD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Understand and voluntarily sign an informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Disease-specific criteria (Phase I):
- Disease Specific Criteria (Phase II)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry
Key exclusion criteria (14 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Unwilling or unable to participate with Food and Drug Administration (FDA) mandated birth control and pregnancy guidelines
- Any condition, including the presence of laboratory abnormalities, which places the patient 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 therapy within 28 days of baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdarubicinAlso: Antineoplastic AgentIntravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms. | Drug | Phase I: Dose Escalation, Phase II: Treatment at MTD |
| CytarabineAlso: Antineoplastic AgentIntravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms. | Drug | Phase I: Dose Escalation, Phase II: Treatment at MTD |
| Lenalidomide (Revlimid®)Also: Revlimid®Lenalidomide as outlined in Phase I and Phase II Treatment Arms. | Drug | Phase I: Dose Escalation, Phase II: Treatment at MTD |
Primary outcome
Phase I: Recommended Phase II Dose
Time frame: 18 months
For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.
Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)
Time frame: 24 months
Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).
3 secondary outcomes
Rate of Lenalidomide Related Toxicity During Maintenance Therapy
Time frame: 24 months
Median Progression-Free Survival (PFS)
Time frame: 24 months
Median Overall Survival (OS)
Time frame: Up to 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Lancet, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Idarubicin, Cytarabine and Lenalidomide (Revlimid®) in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Recommended Phase II Dose (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.