Leukemia, Myeloid, AcutePhase 1/2NCT01016600
Azacitidine and Lenalidomide for Acute Myeloid Leukemia
A Phase 1/2 study testing Lenalidomide and Azacitidine in people with Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Lenalidomide and Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2014
- 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
- Newly diagnosed AML age ≥ 60 years, de novo, secondary to prior therapy, or transformed from MDS, as defined by the International Working Group, except acute promyelocytic leukemia (AML M3) will be included for phase 1 and 2 study. Patients must not have abnormalities of inversion 16, t(16,16), del(16q), t(8,21) or t(15,17) as assessed by routine cytogenetics or FISH. Diagnosis of AML by WHO criteria (>20% blasts) is determined by CBC, bone marrow assessment, and immunophenotypic analysis performed within 2 weeks of study enrollment. No previous treatment for AML, however hydroxyurea, steroids, and leukopheresis are allowed.
- Relapsed AML age ≥18 years, except acute promyelocytic leukemia (AML M3), with CR < 1 years post 1st induction chemotherapy will be included in phase 1 study only.
- Primary refractory AML age ≥18 years, except acute promyelocytic leukemia (AML M3) post 1st induction chemotherapy will be included in phase 1 study only.
- Relapsed or refractory AML age ≥18 years, except acute promyelocytic leukemia (AML M3), post 1st salvage chemotherapy/ autologous stem transplantation/ allogeneic stem cell transplantation will be included in phase 1 study only.
- Understand and voluntarily sign an informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
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- ECOG performance status of ≤ 2 at study entry
- Life expectancy > 2 months
- WBC < 10,000 x 10^6/L (WBC counts may not be reduced by hydroxyurea or leukapheresis to achieve a WBC lower than 10,000 x 106 /L).
- Adequate renal and hepatic function as defined by:
- Serum creatinine ≤ 1.5X institution ULN
- Total bilirubin ≤ 2.0 mg/dL ( except Gilbert's syndrome or known hemolysis)
- AST(SGOT) and ALT (SGPT) ≤ 2.5 x ULN
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®.
- Females of 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 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. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- Men must agree not to father a child and agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. -Disease free of prior malignancies for ≥ 5 years with exception of AML, currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
Who cannot join
- Newly diagnosed AML age < 60 years.
- Newly diagnosed AML ≥ 60 years with favorable risk cytogenetic abnormalities as defined by SWOG criteria that include: inv(16)/t(16;16)/del(16q), t(15;17) with/without secondary aberrations, t(8;21) lacking del(9q) or complex karyotype 17. Prior to enrollment, FISH studies or routine cytogenetics must be completed to rule out these cytogenetic abnormalities.
- Known CNS leukemia
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- 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 therapy within 30 days of enrollment.
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- Known hypersensitivity to thalidomide and mannitol.
- The development of erythema multiforme if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide
- Any prior use of azacytidine.
- Concurrent use of other anti-cancer agents or treatments (with the exception of steroids)
- Known positive for HIV or infectious hepatitis, type A, B or C.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase I/II Trial of Azacitidine Plus Lenalidomide in the Treatment of Acute Myeloid Leukemia
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia
Read the detailed description
Primary:
Phase 1:
To determine the toxicity and feasibility of combining lenalidomide and azacitidine in patients with relapsed/ refractory AML ≥ 18 years or untreated AML ≥60 years.
Phase 2:
To assess the complete remission (CRm plus CRi) rate after lenalidomide + azacitidine therapy in untreated AML ≥60 years.
Secondary:
- To assess the response rate (RR), morphologic leukemia-free state, morphologic complete remission rate (CRm), cytogenetic CR (CRc) rate, CR with incomplete blood counts 14 rate, and partial remission 15 rate (PR).
- To assess overall survival (OS) and event free survival (EFS).
- To assess time to progression (TTP) in untreated AML ≥60 years.
- To assess relapse free survival (RFS) and duration of CR for complete responders.
- To determine the incidence and severity of other toxicities of lenalidomide in combination with azacitidine.
- Assay the expression levels of cytokines/chemokines in the bone marrow plasma, expression of chemokine receptors/ligands on leukemic blasts important for the AML microenvironment and study the direct cytotoxic effects of lenalidomide, azacitidine and combination of both drugs on cryopreserved AML blast cells.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- Lenalidomide, Azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
AzacitidineDrug
Also called Vidaza
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5 Receives: Drug: Lenalidomide; Drug: Azacitidine |
| Cohort 2 | Experimental | Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5 Receives: Drug: Lenalidomide; Drug: Azacitidine |
| Cohort 3 | Experimental | Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5 Receives: Drug: Lenalidomide; Drug: Azacitidine |
| Phase II | Experimental | Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5 Receives: Drug: Lenalidomide; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)
- The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
- Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.
- Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Measured: Completion of the phase I portion of study (approximately 1 year and 4 months)
Phase I Only - Maximum Tolerated Dose (MTD)
- The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
- Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.
- Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Measured: Completion of the phase I portion of study (approximately 1 year and 4 months)
Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age
- Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment.
- Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Measured: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Secondary outcomes (12)
Response Rate (CRm + CRc + CRi + PR)
- Response rate (CRm + CRc + CRi + PR)
- CRm = morphologic complete remission
- CRc = cytogenetic complete remission
- CRi = morphologic complete remission with incomplete blood count recovery
- PR = partial remission
Measured: Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]
Morphologic Leukemia-free State
Defined as < 5% blasts on the BM aspirate with spicules and a count of >200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.
Measured: Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]
Morphologic Complete Remission Rate (CRm)
Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.
Measured: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Cytogenetic CR (CRc) Rate
Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).
Measured: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
CR With Incomplete Blood Counts Rate
Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
Measured: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Partial Remission Rate (PR)
Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.
Measured: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Overall Survival
Defined as the date of first dose of study drug to the date of death from any cause.
Measured: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Event Free Survival
Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.
Measured: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Time to Progression (TTP)
Defined as the interval from the date of the first dose of study drug to the date of progressive disease.
Measured: Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))
Relapse Free Survival (RFS)
This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.
Measured: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Duration of CR for Complete Responders
Measured: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Toxicity Profile (Grade 3/4 Toxicities)
AML ≥18 years or untreated AML ≥60 years
Measured: 30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startApr 2010
- Primary completionNov 2013
- Study completionOct 2014
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 Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Ravi Vij, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016600
- Sponsor's protocol ID
- 09-1816 / 201101749
- Status last verified
- Aug 2015
- First submitted
- 17 Nov 2009
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Azacitidine Plus Lenalidomide in the Treatment of Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01016600
- Acronym / sponsor ID
- 09-1816 / 201101749
- Conditions
- Leukemia, Myeloid, Acute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Apr 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia
Detailed description
Primary:
Phase 1:
To determine the toxicity and feasibility of combining lenalidomide and azacitidine in patients with relapsed/ refractory AML ≥ 18 years or untreated AML ≥60 years.
Phase 2:
To assess the complete remission (CRm plus CRi) rate after lenalidomide + azacitidine therapy in untreated AML ≥60 years.
Secondary:
- To assess the response rate (RR), morphologic leukemia-free state, morphologic complete remission rate (CRm), cytogenetic CR (CRc) rate, CR with incomplete blood counts 14 rate, and partial remission 15 rate (PR).
- To assess overall survival (OS) and event free survival (EFS).
- To assess time to progression (TTP) in untreated AML ≥60 years.
- To assess relapse free survival (RFS) and duration of CR for complete responders.
- To determine the incidence and severity of other toxicities of lenalidomide in combination with azacitidine.
- Assay the expression levels of cytokines/chemokines in the bone marrow plasma, expression of chemokine receptors/ligands on leukemic blasts important for the AML microenvironment and study the direct cytotoxic effects of lenalidomide, azacitidine and combination of both drugs on cryopreserved AML blast cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Lenalidomide, Drug: AzacitidineInduction regimen (total 2 cycles) Lenalidomide 50 mg PO daily days 1-28 Azacitidine 25 mg/m2 IV days 1-5 Maintenance Regimen Lenalidomide 10 mg PO daily days 1-28 Azacitidine 75 mg/m2 IV days 1-5 |
| Cohort 2 | Experimental | Drug: Lenalidomide, Drug: AzacitidineInduction regimen (total 2 cycles) Lenalidomide 50 mg PO daily days 1-28 Azacitidine 50 mg/m2 IV days 1-5 Maintenance Regimen Lenalidomide 10 mg PO daily days 1-28 Azacitidine 75 mg/m2 IV days 1-5 |
| Cohort 3 | Experimental | Drug: Lenalidomide, Drug: AzacitidineInduction regimen (total 2 cycles) Lenalidomide 50 mg PO daily days 1-28 Azacitidine 75 mg/m2 IV days 1-5 Maintenance Regimen Lenalidomide 10 mg PO daily days 1-28 Azacitidine 75 mg/m2 IV days 1-5 |
| Phase II | Experimental | Drug: Lenalidomide, Drug: AzacitidineInduction regimen (total 2 cycles) Lenalidomide 50 mg PO daily days 1-28 Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5 Maintenance Regimen Lenalidomide 10 mg PO daily days 1-28 Azacitidine 75 mg/m2 IV days 1-5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Newly diagnosed AML age ≥ 60 years, de novo, secondary to prior therapy, or transformed from MDS, as defined by the International Working Group, except acute promyelocytic leukemia (AML M3) will be included for phase 1 and 2 study. Patients must not have abnormalities of inversion 16, t(16,16), del(16q), t(8,21) or t(15,17) as assessed by routine cytogenetics or FISH. Diagnosis of AML by WHO criteria (>20% blasts) is determined by CBC, bone marrow assessment, and immunophenotypic analysis performed within 2 weeks of study enrollment. No previous treatment for AML, however hydroxyurea, steroids, and leukopheresis are allowed.
- Relapsed AML age ≥18 years, except acute promyelocytic leukemia (AML M3), with CR < 1 years post 1st induction chemotherapy will be included in phase 1 study only.
- Primary refractory AML age ≥18 years, except acute promyelocytic leukemia (AML M3) post 1st induction chemotherapy will be included in phase 1 study only.
- Relapsed or refractory AML age ≥18 years, except acute promyelocytic leukemia (AML M3), post 1st salvage chemotherapy/ autologous stem transplantation/ allogeneic stem cell transplantation will be included in phase 1 study only.
- Understand and voluntarily sign an informed consent form.
Key exclusion criteria (12 listed)
- Newly diagnosed AML age < 60 years.
- Newly diagnosed AML ≥ 60 years with favorable risk cytogenetic abnormalities as defined by SWOG criteria that include: inv(16)/t(16;16)/del(16q), t(15;17) with/without secondary aberrations, t(8;21) lacking del(9q) or complex karyotype 17. Prior to enrollment, FISH studies or routine cytogenetics must be completed to rule out these cytogenetic abnormalities.
- Known CNS leukemia
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- 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.
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 |
|---|---|---|
| LenalidomideAlso: Revlimid | Drug | Cohort 1, Cohort 2, Cohort 3, Phase II |
| AzacitidineAlso: Vidaza | Drug | Cohort 1, Cohort 2, Cohort 3, Phase II |
Primary outcome
Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)
Time frame: Completion of the phase I portion of study (approximately 1 year and 4 months)
* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. * Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle. * Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Phase I Only - Maximum Tolerated Dose (MTD)
Time frame: Completion of the phase I portion of study (approximately 1 year and 4 months)
* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. * Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle. * Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age
Time frame: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
* Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. * Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.
12 secondary outcomes
Response Rate (CRm + CRc + CRi + PR)
Time frame: Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]
Morphologic Leukemia-free State
Time frame: Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]
Morphologic Complete Remission Rate (CRm)
Time frame: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Cytogenetic CR (CRc) Rate
Time frame: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
CR With Incomplete Blood Counts Rate
Time frame: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Partial Remission Rate (PR)
Time frame: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Overall Survival
Time frame: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Event Free Survival
Time frame: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Time to Progression (TTP)
Time frame: Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))
Relapse Free Survival (RFS)
Time frame: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))
Duration of CR for Complete Responders
Time frame: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)
Toxicity Profile (Grade 3/4 Toxicities)
Time frame: 30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Ravi Vij, M.D. principal investigator
Washington University School of Medicine
1 site 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 Lenalidomide and Azacitidine in people with Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 1 site 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 16 inclusion and 12 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Sep 2015). 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 Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs) (time frame: Completion of the phase I portion of study (approximately 1 year and 4 months)). The study lists 3 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 7 Sep 2015.