NCT00352001 · REGISTRY CONDITION SEARCH

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2018-09-19

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

PHASE I: Maximum Tolerated Dose of Azacitidine

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outcome · POSTED

PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)

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outcome · POSTED

PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)

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outcome · POSTED

Time to Transformation to Acute Myeloid Leukemia or Death

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outcome · POSTED

Time to Relapse After Achieving Complete Response

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outcome · POSTED

Number of Patients That Experience Grade 3 or 4 Treatment Related Non-hematologic Adverse Events

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outcome · POSTED

PHASE I: Maximum Tolerated Dose of Lenalidomide

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outcome · POSTED

Overall Survival Among Patients With Complete Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Diagnosis of myelodysplastic syndromes (MDS) meeting one of the following criteria: * French-American-British histological classification criteria * Refractory anemia with excess blasts (RAEB), defined as 5-19% myeloblasts in the bone marrow * Patients with 20% blasts are considered to have acute myeloid leukemia (per WHO classification system) and are therefore excluded in this study * Chronic myelomonocytic leukemia (CMML), defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood * WHO histological classification criteria * RAEB-1, defined as 5-9% myeloblasts in the bone marrow * RAEB-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood * CMML-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood * International Prognostic Scoring System (IPSS) score of intermediate 2 (1.5-2.0 points based on karyotype, cytopenias, and bone marrow blast percentage) or high (≥ 2.5 points), in the setting of ≥ 5% myeloblasts * Considered ineligible for bone marrow transplantation as first-line therapy PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after completion of study treatment * No serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the treating physician, would preclude study participation or preclude giving informed consent * No preexisting neurotoxicity or neuropathy ≥ grade 2 * No rash or prior hypersensitivity or allergic reaction ≥ grade 3 to thalidomide * Creatinine ≤ 2.0 mg/dL * AST and ALT ≤ 2.0 times upper limit of normal * Bilirubin ≤ 2 mg/dL * Platelet count ≥ 50,000/mm\^3 * Absolute neutrophil count ≥ 500/mm\^3 * No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No history of thromboembolic event or other condition requiring use of anticoagulation with warfarin or low molecular-weight heparin * No known or suspected hypersensitivity to azacitidine or mannitol PRIOR CONCURRENT THERAPY: * More than 28 days since prior and no other concurrent investigational agents for MDS * More than 28 days since prior approved therapy for MDS * More than 14 days since prior growth factors * More than 28 days since prior and no concurrent supraphysiologic doses (equivalent to \> 10 mg/day of prednisone) of corticosteroids * More than 12 months since prior radiotherapy, chemotherapy, or cytotoxic therapy for treatment of conditions other than MDS * No prior lenalidomide or azacitidine * No prior stem cell or bone marrow transplantation * No concurrent androgens, epoetin alfa, or chemotherapy for MDS
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: azacitidine
Drug: lenalidomide
label
Lenalidomide and Azacitidine
type
EXPERIMENTAL

interventions

arm Group Labels
Lenalidomide and Azacitidine
description
Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
name
azacitidine
other Names
Vidaza®
type
DRUG
arm Group Labels
Lenalidomide and Azacitidine
description
Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
name
lenalidomide
other Names
Revlimid®
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 37
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard "3+3" design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.
measure
PHASE I: Maximum Tolerated Dose of Azacitidine
time Frame
After 1 courses (1 months)
description
For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement. Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones. Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality. Hematologic Improvement (HI) is defined as: red blood cell increase of \>=1.5g/dL, a platelet response of \>=30X10\^9/L or by at least 100% for values starting \<20X10\^9/L, or a neutrophil response of at least 100% and absolute increase of \>0.5X10\^9/L
measure
PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)
time Frame
After 4 courses (4 months)
description
For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement) Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones. Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality. Hematologic Improvement (HI) is defined as: red blood cell increase of \>=1.5g/dL, a platelet response of \>=30X10\^9/L or by at least 100% for values starting \<20X10\^9/L, or a neutrophil response of at least 100% and absolute increase of \>0.5X10\^9/L
measure
PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)
time Frame
After 7 courses (months)
description
Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard "3+3" design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.
measure
PHASE I: Maximum Tolerated Dose of Lenalidomide
time Frame
After 1 courses (1 months)

secondary Outcomes

description
Time (in months) patients took to evolve to myeloid leukemia or death after achieving a complete response using the RECIST criteria
measure
Time to Transformation to Acute Myeloid Leukemia or Death
time Frame
After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months
measure
Time to Relapse After Achieving Complete Response
time Frame
After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months
measure
Number of Patients That Experience Grade 3 or 4 Treatment Related Non-hematologic Adverse Events
time Frame
After 7 months
description
Time (in months) patients who achieved a complete response using the RECIST criteria were alive on study
measure
Overall Survival Among Patients With Complete Response
time Frame
After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months

Full study description

brief Summary: RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes.
detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and azacitidine in patients with advanced myelodysplastic syndromes (MDS). Secondary * Review clinical outcomes, as defined by the International Working Group criteria, in patients treated with this regimen. * Determine time to transformation to acute myeloid leukemia or death in patients treated with this regimen. * Determine time to relapse after achieving complete or partial remission in patients treated with this regimen. * Determine time to disease progression in patients treated with this regimen. * Determine the effect of this regimen on hematologic status (including peripheral blood counts and the need for platelet and/or red blood cell transfusions) in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive oral lenalidomide once daily on days 1-14 or days 1-21 and azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses and/or increasing dosing frequencies of lenalidomide and azacitidine until the maximum tolerated dose (MTD) is determined or the sixth dose level is reached, whichever occurs first. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of therapy. After completion of study treatment, patients are followed annually.

Source references

references

citation
Sekeres MA, Tiu RV, Komrokji R, Lancet J, Advani AS, Afable M, Englehaupt R, Juersivich J, Cuthbertson D, Paleveda J, Tabarroki A, Visconte V, Makishima H, Jerez A, Paquette R, List AF, Maciejewski JP. Phase 2 study of the lenalidomide and azacitidine combination in patients with higher-risk myelodysplastic syndromes. Blood. 2012 Dec 13;120(25):4945-51. doi: 10.1182/blood-2012-06-434639. Epub 2012 Aug 22.
pmid
22915641
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice